MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH GRASPING FORCEPS, SHARK TEETH, 7 FR., SEMIFLEXIBLE

Model Number	A4829
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to an olympus repair facility, and an evaluation of the device was performed.During the evaluation, the customer's originally reported issue of tip broken was confirmed; microscopic examination revealed that the clamping pin of the front grasping component was detached.This disconnection of the jaws was identifies as being the result of improper external force during operation the following additional findings were also noted: rust noted in the cracks of the device, and bent and deformed insertion section.The investigation is ongoing, and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation, or if any additional information is provided by the user facility.
Event or Problem Description
The customer reported that, during a diagnostic hysteroscopy, their grasping forceps, shark teeth, 7 fr., semiflexible device was found to have a broken tip.The customer confirmed that no broken pieces of the device fell into the patient¿s cavity.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 provided by the customer.Fields updated: b5, h10.
Event or Problem Description
The customer later reported additional information regarding the event.The original procedure was reportedly a diagnostic hysteroscopy which was completed successfully with a similar device.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 definitive root cause of the broken tip could not be determined.It is possible that the issue was caused by the use of excessive force by the user or improper reprocessing.Olympus will continue to monitor field performance for this device.

• Brand Name: GRASPING FORCEPS, SHARK TEETH, 7 FR., SEMIFLEXIBLE
• Common Device Name: FORCEPS
• 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: 17221522
• Report Number: 9610773-2023-01754
• Device Sequence Number: 14209151
• Product Code: NWW
• UDI-Device Identifier: 04042761006927
• UDI-Public: 04042761006927
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/29/2023

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: A4829
• Device Catalogue Number: A4829
• Device Lot Number: 22XW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2023
• 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: 05/29/2023
• Supplement Date Received by Manufacturer: 07/07/2023; 08/15/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 07/31/2023; 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2022
• 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: OTV-S300.
• Patient Sex: Unknown