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

Model Number	A20712A
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2024
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 9610773-2024-00285
• Device Sequence Number: 15735293
• Product Code: GCP
• UDI-Device Identifier: 04042761020008
• UDI-Public: 04042761020008
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K790071
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2024
• Supplement Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2022
• 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