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

Model Number	FB-231D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The wire detached from the fixing hole of the cup.A part of the wire which was crimped to fix the hole was missing.The fixing hole had scratch.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases, it was known that the wire detachment and the wire missing might occur due to any of the following possible causes.The wire was subjected to a load since the user forcibly withdrew the subject device from angulated endoscope.The wire was subjected to a load since the user forcibly pulled the slider of the subject device while the insertion portion of the subject device was rounded small.The instruction manual of the device has already warned as follows: 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
During a bronchial biopsy, subject device was used.The cup of the subject device was not open.The intended procedure was continued with another device.On march 6, 2019, olympus medical systems corp.(omsc) found that the wire of subject device was partially missing.No patient injury was reported.This is the report regarding the missing wire.

• 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: 8423667
• Report Number: 8010047-2019-01288
• Device Sequence Number: 2051381
• Product Code: EOQ
• UDI-Device Identifier: 04953170389559
• UDI-Public: 04953170389559
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K950636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/15/2019

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: 83V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 03/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1