MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH BIOPSY FORCEPS, SPOON TYPE, OPTICAL, FOR 12° TELESCOPE; RIGID ENDOTHEREAPY BIOPSY FORCEPS, REUSABLE

Model Number A20712A

Device Problem Difficult to Open or Close (2921)

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

Event Date 01/14/2024

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation, and the evaluation found that the screw at the base of the handle had come loose.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

It was reported that the biopsy forceps's tip did not open and close when the handle was opened and closed.The autoclave was used as specified.The issue was found during preparation for use.There were no reports of patient harm.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of 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.It has been over 1 years since the subject device was manufactured.The device was returned to olympus for inspection, and the customer's allegation that the tip did not open and close when the handle was opened and closed was confirmed.Based on the results of the investigation, it was likely that the event was caused by wear and tear, poor maintenance, or improper handling.Olympus will continue to monitor field performance for this device.

• Brand Name: BIOPSY FORCEPS, SPOON TYPE, OPTICAL, FOR 12° TELESCOPE
• Type of Device: RIGID ENDOTHEREAPY BIOPSY FORCEPS, REUSABLE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg/de/germany 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg/de/germany
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18605398
• MDR Text Key: 335102175
• Report Number: 9610773-2024-00285
• Device Sequence Number: 1
• Product Code: GCP
• UDI-Device Identifier: 04042761020008
• UDI-Public: 04042761020008
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K790071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

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
• Device Operator: Health Professional
• Device Model Number: A20712A
• Device Lot Number: 22702-0011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/14/2024
• Initial Date FDA Received: 01/30/2024
• Supplement Dates Manufacturer Received: 04/30/2024
• Supplement Dates FDA Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2022
• 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