MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH JAWS "HIQ+", BIPOLAR, 5 X 330 MM, GRASPING FORCEPS, FENESTRATED; BIPOLAR GRASPING FORCEPS BIQ+

Model Number	WA64120C
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.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.
Event or Problem Description
The customer reported to olympus, the jaws "hiq+" white part of the jaw on the product had white insulation that was worn on several products.There were no reports of patient harm.
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.Device evaluation also found scratch marks.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, it is likely that the event occurred due to either a quality issue or the reprocessing method and/or the service life.The definitive root cause was unable to be determined.The event can be prevented by following the instructions for use (ifu): before use, the product must be checked for the following (see also ifu, chapter 4.2.2 ¿specific inspection¿): any type of deformation, dents, cracks, deep scratches, defects in and at the insulation, dirt, corrosion, and labelling visibility.Olympus will continue to monitor field performance for this device.

• Brand Name: JAWS "HIQ+", BIPOLAR, 5 X 330 MM, GRASPING FORCEPS, FENESTRATED
• Common Device Name: BIPOLAR GRASPING FORCEPS BIQ+
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17916341
• Report Number: 9610773-2023-02884
• Device Sequence Number: 11505972
• Product Code: GEI
• UDI-Device Identifier: 04042761062411
• UDI-Public: 04042761062411
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2023

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: WA64120C
• Device Lot Number: 20311-0018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/06/2023
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 12/07/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown