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

Model Number A4829

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/25/2023

Event Type  malfunction  

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 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.

• Brand Name: GRASPING FORCEPS, SHARK TEETH, 7 FR., SEMIFLEXIBLE
• Type of Device: 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 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18341525
• MDR Text Key: 331056031
• Report Number: 9610773-2023-03652
• Device Sequence Number: 1
• Product Code: NWW
• UDI-Device Identifier: 04042761006927
• UDI-Public: 04042761006927
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A4829
• Device Lot Number: 225W
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1