MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH BIOPSY FORCEPS, SPOON TYPE, OPTICAL, FOR 30° TELESCOPE; RIGID ENDOTHERAPY BIOPSY FORCEPS, REUSABLE

Model Number	A20713A
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported the rigid endotherapy biopsy forceps tip did not open.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.The device was not returned to olympus for inspection, therefore the reportable malfunction could not be confirmed.A definitive root cause was not identified, however based on the results of the investigation, the probable cause of the malfunction would likely be caused by wrong handling, excessive force.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported the rigid endotherapy biopsy forceps tip did not open.The issue occurred during inspection for use.There were no reports of patient harm.

• Brand Name: BIOPSY FORCEPS, SPOON TYPE, OPTICAL, FOR 30° TELESCOPE
• Common Device Name: RIGID ENDOTHERAPY BIOPSY FORCEPS, REUSABLE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19651304
• Report Number: 9610773-2024-01604
• Device Sequence Number: 12401463
• Product Code: GCP
• UDI-Device Identifier: 04042761020015
• UDI-Public: 04042761020015
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2024

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: A20713A
• Device Lot Number: 0000000
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/20/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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