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	01/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus.The cause of the reported event could not be confirmed at this time.As a preventive measure, the instruction manual provides several warnings which states: "do not withdraw the instrument from the endoscope while the cups are open.Doing so could damage the endoscope and/or instrument"."if excessive resistance makes withdrawal difficult, adjust the angle of the endoscope until the instrument can be withdrawn smoothly.Forcible withdrawal could damage the instrument and/or endoscope"."do not withdraw the biopsy forceps while the endoscope is angulated.Doing so could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 manipulation wire may stick out and damage the endoscope and/or cause bleeding or damage the mucous membrane.Using the equipment with a detached manipulation wire could cause bleeding or damage to the mucous membrane.Using the equipment with a detached manipulation wire could cause bleeding or damage to the mucous membrane".
Event or Problem Description
The user facility reported that during a bronchoscopy procedure the jaws broke off into the scope while the device was being withdrawn; it never fell into the patient.There was no patient harm.The procedure was completed successfully.In addition, user facility reported that the before the breakage, the bronchoscope was flexed to the right upper lobe (rul) apical segment in order to obtain a biopsy.The forceps would not advance and was withdrawn.The bronchoscope was then backed out slightly and straightened out.The forceps was advanced again and then the scope was flexed into the rul apical segment again.The scope could not flex adequately and the scope was again straightened out.The bronchoscope was retracted and forceps removed.A new biopsy location in the lingual was then chosen as an alternate site.Prior to re-inserting the forceps the technician noted that one of the forceps arms was missing.A search was performed for the missing part.It was found in the filter of the suction canister.The procedure was then completed without difficulty and with no adverse patient effect.The only procedural issue was not being able to get biopsies from the original rul apical segment location.The physician was experienced in the use of the forceps.No undue force was used or detected with the forceps during the procedure.There were no reported anatomical anomalies in the patient.

• 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: 8654595
• Report Number: 2951238-2019-00887
• Device Sequence Number: 19394965
• Product Code: EOQ
• UDI-Device Identifier: 04953170158124
• UDI-Public: 04953170158124
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K950636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/30/2019

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: Health Professional
• Device Model Number: FB-211D
• Device Lot Number: 8SA822
• 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: 01/10/2019
• Initial Report FDA Received Date: 05/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1