MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. BIOPSY FORCEPS

Model Number	FB-36K-1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the device was not returned to olympus for evaluation, a root cause for the reported event cannot be determined.If additional information becomes available or the device is returned for evaluation, a supplemental report will be submitted.
Event or Problem Description
Olympus was informed of a report that the biopsy forceps, model number fb-36k-1, tip broke inside a patient during the procedure.It was reported that the endoscope was removed in order to allow removal of the broken device since the forceps were trapped and rotated inside the patient's stomach.The intended diagnostic procedure was completed; the same device was not used to complete the procedure.There was no patient injury, associated with the event, reported to olympus.
Additional 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 (dhr) found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the probable cause is likely some bending force was applied to the forceps and/or the distal tip of the forceps was corroded.This issue is addressed in the instructions for use (ifu): "before use, confirm that the pins are fully seated at the forceps¿ distal end as shown on page 8; it should not be sticking out.Do not use the forceps if the pins are sticking out, as it could fall out inside the patient, injure the mucous membrane, or damage the forceps and/or the endoscope¿s instrument channel.If the pins fall out inside the patient during use, stop the procedure immediately and retrieve the pins using another grasping forceps.Before use, confirm that the distal tip of the forceps is not corroded, dented or discolored, and that the cups can be opened and closed smoothly.Using forceps that are damaged or not working properly may result in one or more of its components falling off inside the patient.If a component falls off of the distal end, or if operation of the cups suddenly becomes more difficult, immediately stop the procedure.Carefully withdraw the forceps together with the endoscope to avoid causing injury within the body cavity.Retrieve any parts that have fallen off inside the patient using another grasping forceps.".

• Brand Name: BIOPSY FORCEPS
• Common Device Name: BIOPSY FORCEPS
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11729358
• Report Number: 8010047-2021-05441
• Device Sequence Number: 3549954
• Product Code: EOQ
• UDI-Device Identifier: 04953170030314
• UDI-Public: 04953170030314
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K962555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2021

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: FB-36K-1
• Device Lot Number: K9422-2492
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/28/2021
• Supplement Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 07/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1