MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH JAWS "HIQ+", BIPOLAR, 5 X 330 MM, DISSECTION FORCEPS, MARYLAND; RESECTOSCOPE

Model Number	WA64360C
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, the root of the jaws was loose, and sparks appeared when output.The case was completed with the same set of equipment.There were no reports of patient harm.
Additional Manufacturer Narrative
The device was returned.The evaluation found the insulation pad at the tip of the jaw was worn, and the insulation outer cover at the end was chipped.The wear of the insulation pad at the tip was caused by normal wear and tear during use, while the damage to the insulation outer cover at the end may be caused by the abrasion of the jaw core against the sleeve rod during installation or during cleaning and disinfection.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Additional information added to field h6.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 years since the subject device was manufactured.The device was returned to olympus for inspection, and the customer's complaint that the root of the jaws was loose, and sparks appeared when output was confirmed.Based on the results of the investigation, it is likely that the event occurred due to the wear and tear and improper handling, frequent usage and reprocessing.Also, it can be assumed that severe hf flashover was caused by unintentional contact with other equipment or the distal jaws were constantly touching during hf application without tissue contact, resulting in a short circuit in the device.Olympus will continue to monitor field performance for this device.

• Brand Name: JAWS "HIQ+", BIPOLAR, 5 X 330 MM, DISSECTION FORCEPS, MARYLAND
• Common Device Name: RESECTOSCOPE
• 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: 18788600
• Report Number: 9610773-2024-00542
• Device Sequence Number: 7832123
• Product Code: HET
• UDI-Device Identifier: 04042761068611
• UDI-Public: 04042761068611
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K944201
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2024

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: Health Professional
• Device Model Number: WA64360C
• Device Lot Number: 23402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2023
• 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
• Patient Sex: Unknown