MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH JAWS INSERT "HICURA", 5 X 330, WAVE TYPE, MONOPOLAR; RIGID ENDOSCOPIC TISSUE MANIPULATION FORCEPS, REUSABLE

Model Number	WA69334M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the rigid endoscopic tissue manipulation forceps distal end of the jaw was broken or deformed.There were no reports of patient harm.
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.However, the likely cause of the reported event is due to excessive force/wrong handling.A deformation at the distal end or a mouth misalignment of greater than or equal to 0.5mm is due to the action of a large mechanical force.Furthermore, a jaw offset of less than or equal to 0.5mm is permissible.Olympus will continue to monitor field performance for this device.

• Brand Name: JAWS INSERT "HICURA", 5 X 330, WAVE TYPE, MONOPOLAR
• Common Device Name: RIGID ENDOSCOPIC TISSUE MANIPULATION FORCEPS, REUSABLE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg/de/germany 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg/de/germany
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19999880
• Report Number: 9610773-2024-02007
• Device Sequence Number: 4929407
• Product Code: GEI
• UDI-Device Identifier: 04042761079426
• UDI-Public: 04042761079426
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K140624
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2024

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: WA69334M
• Device Lot Number: 23Z01 23Z02
• Was Device Available for Evaluation?: No
• 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: 07/29/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 08/19/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2023
• 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