MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH JAWS INSERT "HICURA", 5 X 330, JOHANN, BIPOLAR; HICURA HAND INSTRUMENTS

Model Number	WA69410M
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported to olympus that when this hicura hand instrument was inserted into the abdominal cavity and an attempt was made to grip the tissue, the jaw at the tip fell off.The fallen part has been recovered.The procedure was completed using another forceps.The issue occurred at the first use after borrowing the demo machine.The device was inspected with no abnormalities noted prior to use.There were no reports of further patient or user harm associated with this event.
Additional Manufacturer Narrative
To date, this device has not been returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
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 was returned to olympus for inspection, and the following was observed: it was confirmed that the shaft for opening and closing the forceps, and the tip of the forceps were broken.The forceps were broken at the axis.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been more than 1 year since the subject device was manufactured.Based on the results of the investigation, the breakage of the forceps (at distal end) can be attributed to the application of excessive force and wear and tear due to material fatigue.This supplemental report includes a correction to d4, g2, and h3 from the initial medwatch.Also, information has been added to d9 and h4.Olympus will continue to monitor field performance for this device.

• Brand Name: JAWS INSERT "HICURA", 5 X 330, JOHANN, BIPOLAR
• Common Device Name: HICURA HAND INSTRUMENTS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17551974
• Report Number: 9610773-2023-02248
• Device Sequence Number: 12478517
• Product Code: GEI
• UDI-Device Identifier: 04042761079976
• UDI-Public: 04042761079976
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140624
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: WA69410M
• Device Lot Number: 22X03-0012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2023
• Supplement Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: WA69400M(L/175W).WA69002M(L/173W).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown