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

Model Number	WA64320C
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, the jaws, bipolar, 5 x 330 mm, preparation forceps, had damaged insulation.The issue was found during reprocessing.There were no reports of patient harm.
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.The inspection results are evaluated as plausible.According to the event description, the customer reported a damaged insulation.The service department confirms this issue and identifies the following: slightly bent control rod damaged teflon coating based on the results of the investigation, it is likely that the following led to the malfunction: damaged insulation: the cause is very likely incorrect reprocessing, in combination with wear and tear.A device history review revealed no issues that could have caused or contributed to the reported issue.Olympus will continue to monitor the field performance of this device.

• Brand Name: JAWS "HIQ+", BIPOLAR, 5 X 330 MM, PREPARATION FORCEPS, MARYLAND, SHORT
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, deutschland 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18243819
• Report Number: 9610773-2023-03446
• Device Sequence Number: 7108303
• Product Code: GEI
• UDI-Device Identifier: 04042761062442
• UDI-Public: 04042761062442
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/30/2023

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: 199W-0053
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2023
• Initial Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2019
• 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