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 Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation.If additional information becomes available prior to the conclusion of the investigation, a supplemental report will be filed.
Event or Problem Description
The customer reported that the handle on his olympus bioplar hiq jaws broke during a procedure and the device began producing a burning smell.According to the initial reporter, the procedure was delayed approximately 5-minutes while a new device was exchanged.Once the device was replaced, the procedure was continued without any report of patient harm or other device failures.
Event or Problem Description
The intended procedure was a therapeutic laparoscopy.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for inspection, and the customer's complaint was confirmed.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, the root cause could not be conclusively determined.It is likely the reported event occurred due to incorrect reprocessing in combination with wear and tear.In addition, the following non-reportable malfunctions were found during the device evaluation: overload safety device was deformed and the shaft insulation at the proximal end was damaged.(b)(6) has been opened for the shaft "hiq+", bipolar, 5 x 330 mm, isolated (wa60800c).(b)(6) has been opened for the handle "hiq+", ergo, bipolar (wa60101c).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: 17772964
• Report Number: 9610773-2023-02625
• Device Sequence Number: 20637842
• Product Code: GEI
• UDI-Device Identifier: 04042761062442
• UDI-Public: 04042761062442
• Combination Product (Y/N): N
• Initial Reporter Country: CY
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2023

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 Lot Number: 21Y05-0003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2023
• Supplement Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2021
• 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