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

Model Number	FB-211D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The devices were not returned to olympus for evaluation.The exact cause for the reported event cannot be determined at this time.The most likely cause of the reported event can be attributed to user handling.The instruction manual of the subject device warns: do not withdraw the biopsy forceps while the endoscope is angulated.Doing so could cause the manipulation wire to detach from the cups.A part of manipulation wire could be damaged and detached to fall off into the patient's body or the wire may stick out and damage the endoscope and/or cause bleeding or damage the mucous membrane.Using the equipment with a detached wire could cause bleeding or damage to the mucous membrane.
Event or Problem Description
Olympus was informed that during a diagnostic bronchoscopy procedure, the jaws from two forceps broke allowing the wires to protrude from the distal end of the devices.No device fragment fell into the patient.It was reported that there was a popping noise noted when the jaws closed.The doctor was able to retrieve the intended specimens.There was no unusual bleeding observed.The intended procedure was completed with a third similar device.There was no patient injury.This is report 1 of 2.

• Brand Name: DISPOSABLE BIOPSY FORCEPS
• Common Device Name: DISPOSABLE 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: 8192345
• Report Number: 2951238-2018-00799
• Device Sequence Number: 19307930
• Product Code: EOQ
• UDI-Device Identifier: 04953170158124
• UDI-Public: 04953170158124
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K950636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/21/2018

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-211D
• Device Catalogue Number: FB-211D
• Device Lot Number: 8SA718
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 12/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1