Z-0432-2014Class II

TB-0545PC: THUNDERBEAT 5 mm , 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm, 35 em, Pi stol Grip TB-0545IC...

Name: Z-0432-2014 TB-0545PC: THUNDERBEAT 5 mm , 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm, 35 em, Pi stol Grip TB-0545IC...
Creator: Olympus America Inc.
Published: 2013-09-27
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2013-09-27 / Terminated

FDA source

Olympus America Inc. began a recall of TB-0545PC: THUNDERBEAT 5 mm , 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm, 35 em, Pi stol Grip TB-0545IC: THUNDERBEAT 5 mm, 45 em, In line Grip TB-0535IC... on 2013-09-27. FDA classified it as Class II and gives the reason as "Complaints of damage to various models of Thunderbeat Hand Instruments during surgical procedures, including cracking, breaking, or deformation of the components of the probe tip or jaw". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0432-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-27
Posted: 2013-12-05
Terminated: 2015-02-02
Recalling firm: OLYMPUS Corporation of the Americas
Product: TB-0545PC: THUNDERBEAT 5 mm , 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm, 35 em, Pi stol Grip TB-0545IC: THUNDERBEAT 5 mm, 45 em, In line Grip TB-0535IC: THUNDERBEAT 5 mm, 35 em, Inline Grip TB-0520IC: THUNDERBEAT 5 mm, 20 em, In line Grip TB-051 OIC: THUNDERBEAT 5 mm, I 0 em, In line Grip TB-545FC: THUNDERBEAT 5 mm, 45 em, Front Actuated Grip TB-0535FC: THUNDERBEAT 5 mm, 35 em, Front Actuated Grip The Olympus Thunderbeat Surgical Tissue Management System ("Thunderbeat") is intended to be used for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Complaints of damage to various models of Thunderbeat Hand Instruments during surgical procedures, including cracking, breaking, or deformation of the components of the probe tip or jaw.
FDA root cause: Use error
Action: Olympus sent an Urgent Medical Device Field Correction Action letter dated September 27, 2013, to all affected customers. The letter identified the product the problem and the actions needed to be taken by the customer. Please make the attached Procedural Tips and Techniques instructions available to all users of the THUNDERBEAT hand instruments. Please also maintain a copy with the Instruction Manual(s) fot"the device. OCA requires that you indicate on the enclosed questionnaire your acknowledgement of receipt of this corrective action and the contact information for your facility. This additional user instruction is also being added to the Instruction Manual(s) for the THUNDERBEAT hand instruments. If you would like a copy of the updated Instruction Manual(s), please contact OAI Customer Service at 1-800-848-9024. For further questions please call (484) 896-5688.
Quantity in commerce: 8709
Distribution: Worldwide Distribution - USA (nationwide) including Puerto Rico and Internationally to Canada.
Product codes and lots: All sold units

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0432-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0432-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-11	2013-12-05

Product code GEI

K111202Class IISurgical Tissue Management SystemOlympus Medical Systems Corp. / cleared 2012-01-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)