MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH SHAFT "HIQ+", BIPOLAR, 5 X 330 MM, ISOLATED; WA60800C

Model Number	WA60800C
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
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 reported that the electrical insulation from the subject device is damaged and leads to unintended thermal damage during activation.The procedure was completed using the same device.The issue occurred during a total laparoscopic hysterectomy (tlh) procedure.There were no reports of patient or user harm associated with this event.
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 history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the reported event was likely due to wear and tear.However, since the device was not returned a definitive root cause of the reported issue could not be confirmed.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being supplemented to provide a correction.Correction h6: type of investigation of the supplemental report to remove "3331 - analysis of production records.".

• Brand Name: SHAFT "HIQ+", BIPOLAR, 5 X 330 MM, ISOLATED
• Common Device Name: WA60800C
• 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: 20706308
• Report Number: 9610773-2024-02690
• Device Sequence Number: 15928570
• Product Code: GEI
• UDI-Device Identifier: 04042761062398
• UDI-Public: 04042761062398
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Foreign,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2025

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: WA60800C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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: 11/13/2024
• Supplement Date Received by Manufacturer: 04/14/2025; 04/29/2025
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 04/29/2025; 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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