MAUDE Adverse Event Report: OLYMPUS CORPORATION OF THE AMERICAS ENDOJAW LARGE BIOPSY FORCEPS SINGLE USE; BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES

Model Number	FB-225U
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Physician was inserting biopsy forceps into the scope when he heard a "pop", he states that normally he hears a slight "pop" the time a device is inserted through the biopsy port cover so he thought that was what this was.When the scope was fully inserted and appeared out the end of the scope, he noted that the distal end of the forceps was bent.Physician removed the forceps and obtained another one, bent one was sequestered for risk.Fda safety report id (b)(4).

• Brand Name: ENDOJAW LARGE BIOPSY FORCEPS SINGLE USE
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES
• Manufacturer (Section D): OLYMPUS CORPORATION OF THE AMERICAS
• MDR Report Key: 10355895
• Report Number: MW5095844
• Device Sequence Number: 16785936
• Product Code: EOQ
• UDI-Device Identifier: 04953170408274
• UDI-Public: (01)04953170408274(17)240630(10)
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/30/2020

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 Expiration Date: 06/30/2024
• Device Model Number: FB-225U
• Device Lot Number: 9 SA726 97V
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 99