MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH JAWS "HIQ+", BIPOLAR, 5 X 330 MM, PREPARATION FORCEPS, MARYLAND, SHORT

Model Number	WA64320C
Medical Device Problem Codes	Break (1069); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, the jaws were unable to be fully closed and the hinge was broken.The issue was found during a laparoscopic total hysterectomy bilateral salpingo-oophorectomy.The damage was detected outside the patient's body by the surgical nurse before the start of the procedure.The jaw insert was neither activated nor used and the procedure was performed using a spare device.There were no reports of patient harm.
Additional Manufacturer Narrative
No further information was able to be provided by the customer.The subject device was returned to an olympus repair center for evaluation and the customer¿s reported problem was confirmed.The device evaluation found that the ceramic axle was broken.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 3 years since the subject device was manufactured.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation (h6/h10).Based on the results of the investigation, the root cause was wear.It is likely the reported event occurred due to acute use related wear and tear as well as improper reprocessing.The ceramic axle connection between the jaw parts was damaged/torn as a result of at least one high-frequency current flashover.The jaw insulation was worn and parts of the insulation/ceramic axle were missing.Olympus will continue to monitor field performance for this device.

• Brand Name: JAWS "HIQ+", BIPOLAR, 5 X 330 MM, PREPARATION FORCEPS, MARYLAND, SHORT
• Common Device Name: JAWS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16950251
• Report Number: 9610773-2023-01355
• Device Sequence Number: 6916037
• Product Code: GEI
• UDI-Device Identifier: 04042761062442
• UDI-Public: 04042761062442
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K984417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2023

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: WA64320C
• Device Catalogue Number: WA64320C
• Device Lot Number: 20305-0011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2023
• 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: 04/17/2023
• Supplement Date Received by Manufacturer: 06/13/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown