MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH JAWS "HIQ+", 5 X 330 MM, GRASPING FORCEPS, CROCEOLMI; LAPAROSCOPE, GYNECOLOGIC AND ACCESSORIES

Model Number	WA64150A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, during the transabdominal preperitoneal (tapp) case, the croce grasping forceps could not be opened or closed normally.The metal connection part for strengthening the opening and closing has come off and was suspected to have fallen off.When the net used in the tapp procedure was grasped from the mineyama trocar, it made a noise and broke.The fallen pieces have not been recovered.The patient was examined with a computed tomography (ct) scan and a metal piece less than 2mm in size was found, however it is unknown if the metal piece was a part of the broken device.Abdominal lavage has been performed.The unit was replaced with another one and the procedure was completed.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Additionally, to provide an update to fields (h3 and h4).The device was evaluated by olympus, and the pull-rod at the distal end is broken.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, it is likely that the reported event occurred due to high force.However, the root cause if the reported event could not be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: JAWS "HIQ+", 5 X 330 MM, GRASPING FORCEPS, CROCEOLMI
• Common Device Name: LAPAROSCOPE, GYNECOLOGIC AND ACCESSORIES
• 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: 19760295
• Report Number: 9610773-2024-01725
• Device Sequence Number: 15739582
• Product Code: HET
• UDI-Device Identifier: 04042761068970
• UDI-Public: 04042761068970
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K944200
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2024

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: WA64150A
• Device Lot Number: 20Y02-020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2024
• 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: 07/02/2024
• Supplement Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2021
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GRASPING FORCEPS A60800A.; WA60103A HANDLE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown