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

Model Number A4829

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

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

Event Date 05/29/2023

Event Type  malfunction  

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 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.

Manufacturer Narrative

This report is being supplemented to provide additional information provided by the customer.Fields updated: b5, h10.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 318081308
• Report Number: 9610773-2023-01754
• Device Sequence Number: 1
• Product Code: NWW
• UDI-Device Identifier: 04042761006927
• UDI-Public: 04042761006927
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2022
• 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
• Treatment: OTV-S300.