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

Model Number	A4829
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that when using a grasping forceps, shark teeth, 7 fr., semiflexible, the forceps would not close.The forceps was removed, and it was noted that one of the screws was loose, and the other screw was missing.The user inspected the uterine cavity under the hysteroscope, and the screw was not seen.The staff searched the area but did not locate the missing screw.The sheath tube was flushed after the procedure and there were no screws found.The therapeutic procedure (endometrial polypectomy) was completed with a similar device.There was minimal delay and a patient under general anesthesia at the time of the event.There was no patient harm associated with the event.
Additional Manufacturer Narrative
The device was sent to a third party for repair; therefore, the customer¿s allegation could not be confirmed.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the root cause of the event was unable to be identified.The event likely occurred due to excessive force in combination with rotational movement or pre-damage (e.G.Due to corrosion).Olympus will continue to monitor field performance for this device.

• Brand Name: GRASPING FORCEPS, SHARK TEETH, 7 FR., SEMIFLEXIBLE
• Common Device Name: BIOPSY 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: 17701790
• Report Number: 9610773-2023-02489
• Device Sequence Number: 7446120
• Product Code: NWW
• UDI-Device Identifier: 04042761006927
• UDI-Public: 04042761006927
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K983811
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2023

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 Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• 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: 08/16/2023
• Supplement Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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-S190 VISERA ELITE VIDEO SYSTEM CENTER.
• Patient Sex: Unknown