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

Model Number	WA60800C
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was evaluated by a third party who observed the internal shaft insulation was damaged.The device was replaced for the customer.The defective part is not expected to be returned to olympus.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 for the malfunction is likely improper handling by the user.However, a definitive root cause cannot be established.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
A third party distributor reported to olympus, the bipolar hand instrument (shaft "hiq+", bipolar, 5 x 330 mm, isolated) could not be taken apart after the procedure.There were no usage problems during the procedure.There were no reports of patient harm.

• Brand Name: SHAFT "HIQ+", BIPOLAR, 5 X 330 MM, ISOLATED
• Common Device Name: SHAFT "HIQ+", BIPOLAR, 5 X 330 MM, ISOLATED
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 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: 16797281
• Report Number: 9610773-2023-01124
• Device Sequence Number: 3252157
• Product Code: GEI
• UDI-Device Identifier: 04042761062398
• UDI-Public: 04042761062398
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: K984417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/24/2023

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: WA60800C
• Device Catalogue Number: WA60800C
• Device Lot Number: 22702-0021
• 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: 02/10/2023
• Initial Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2022
• 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