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

Model Number	WA64120C
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was observed during the device inspection, that the grasping forceps exhibited detachment of the teflon pin on the jaw resulting into the inability to open and close the jaw on one side.There were no reports of patient involvement.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.New information added to the following fields: d8, h6 and h11.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 1 year since the subject device was manufactured.A definitive root cause was not identified, however, based on the results of the investigation, the probable cause of the malfunction would likely be improper handling leading to damage of the ceramic axle.The reported damage, specifically the detachment of the teflon pin, can be attributed to previous damage to the ceramic axle.The melting of the teflon body suggests that the damage to the ceramic axle was caused by a severe high frequency flashover, which is triggered by unintentional contact with other equipment or continuous contact of the distal jaws during high frequency application without tissue contact.This can result in a short circuit within the device, causing the ceramic tip to break, become loose, and possibly fall out.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: RIGID ENDOSCOPIC TISSUE MANIPULATION FORCEPS, REUSABLE
• 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: 19740556
• Report Number: 9610773-2024-01699
• Device Sequence Number: 15383545
• Product Code: GEI
• UDI-Device Identifier: 04042761062411
• UDI-Public: 04042761062411
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K984417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2024

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: Other
• Device Model Number: WA64120C
• Device Lot Number: 23310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: WA60101C; WA60800
• Patient Sex: Unknown