MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. DISPOSABLE BIOPSY FORCEPS

Model Number	FB-231D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was observed during the device inspection, that the disposable biopsy forceps parts broke off.There were no reports of patient involvement.
Additional Manufacturer Narrative
The device was returned and the evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Corrected fields: a1, d8, e2 and e3.Additional information added to field h3 and h6.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, it is likely the operation wire was damaged or fell off and came off from the operation wire fixing hole of the cup because a strong load exceeding the bearing strength was applied to the connection part between the operation wire and the cup.However, a definitive root cause could not be identified.The following is included in the instructions for use (ifu): -never use excessive force to open or close the cups.This could damage the instrument.-if the manipulation wire becomes detached from the cups, immediately stop using the instrument.With the wire detached, you may feel little or no resistance when moving the slider, and your impression of the manipulation of the instrument may differ significantly from what is actually taking place.If you notice any major changes in manipulation, check whether or not the wire has become detached from the cups.-if the manipulation wire becomes detached while the biopsy forceps are inserted in the endoscope, first move the slider all the way in the proximal direction in order that the cups may come as close to the distal end of the endoscope as possible.Then, withdraw the biopsy forceps and the endoscope together from the patient¿s body with extreme care to avoid causing patient injury.At the same time, make sure that no part of the manipulation wire has fallen into the patient's body.-do not force the instrument if resistance to insertion is encountered.Reduce the endoscope¿s angulation (or lower the forceps elevator if applicable) until the instrument passes smoothly.Attempting to force the instrument could cause patient injury, such as perforation, bleeding, or mucous membrane damage.It could also damage the endoscope and/or instrument.Olympus will continue to monitor field performance for this device.

• Brand Name: DISPOSABLE BIOPSY FORCEPS
• Common Device Name: DISPOSABLE BIOPSY FORCEPS
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20087554
• Report Number: 9614641-2024-01733
• Device Sequence Number: 7810276
• Product Code: EOQ
• UDI-Device Identifier: 04953170158209
• UDI-Public: 04953170158209
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K950636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2024

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: Other
• Device Model Number: FB-231D
• Device Lot Number: 3XT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown