MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH JAWS INSERT "HICURA", 5 X 330, CROCEOLMI, MONOPOLAR; FORCEPS

Model Number	WA69320M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus that one of the jaws broke off during reprocessing.There were no reports of patient harm or impact associated with this event.
Additional Manufacturer Narrative
The subject device was returned to an olympus service center for evaluation.Upon inspection and testing of the returned device, the reported issue (broken forceps) was confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.It has been over 2 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, it is likely that damage to the jaws insert was caused during reprocessing.This type of breakage indicates a massive impact by excessive force, wrong/improper handling during reprocessing which can only occur when the jaws are wide open.However, a definitive root cause could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: JAWS INSERT "HICURA", 5 X 330, CROCEOLMI, MONOPOLAR
• Common Device Name: FORCEPS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrabe 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17787612
• Report Number: 9610773-2023-02649
• Device Sequence Number: 15066550
• Product Code: GEI
• UDI-Device Identifier: 04042761079297
• UDI-Public: 04042761079297
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140624
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: WA69320M
• Device Lot Number: 21601-008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2022
• Initial Report FDA Received Date: 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown