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

Model Number	A4829
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.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 to olympus, the patient underwent hysteroscopic examination and removal of intrauterine pregnancy residue under general anesthesia intubation.When preparing to use the grasping forceps during the surgery, it was found that it was unable to clamp the tissue.Upon examination, it was found that the small screw at the front end of the grasping forceps was loose and fell off.Due to the small size of the screw, it was repeatedly searched under the scope and confirmed that no small screw was found in the patient's uterine cavity.Then, a new grasping forceps was immediately replaced to continue the surgery and it was completed.The patient's vital signs remained stable during the surgery, and the process was smooth.The patient returned to the ward safely after the surgery.The user confirmed the missing forceps screw was not found within the patient¿s uterine cavity, and the event did not require an additional intervention or hospitalization to preclude permanent harm or impairment.
Additional Manufacturer Narrative
This supplemental report is to provide a correction to the initial medwatch report (mdr).Further review found there was no reportable malfunction related to the subject device captured in this complaint.The initial mdr was inadvertently submitted as a reportable malfunction.The initial medwatch reported that the small screw at the front end of the grasping forceps was loose and fell off; however, it was confirmed that the event did not occur with an olympus device.Per the legal manufacturer, this issue is not likely to cause or contribute to death or serious injury if the malfunction were to recur.

• Brand Name: GRASPING FORCEPS, SHARK TEETH, 7 FR., SEMIFLEXIBLE
• Common Device Name: FORCEPS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, deutschland 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: 18341525
• Report Number: 9610773-2023-03652
• Device Sequence Number: 6703024
• Product Code: NWW
• UDI-Device Identifier: 04042761006927
• UDI-Public: 04042761006927
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• 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): 08/13/2024

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: A4829
• Device Lot Number: 225W
• 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: 11/30/2023
• Supplement Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2022
• 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
• Patient Sex: Unknown