MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION ENDOJAW LARGE; FORCEPS, BIOPSY, ELECTRIC

Model Number	FB225U
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
Forceps distal end bent as it was being advanced down scope.Fda safety report id# (b)(4).

• Brand Name: ENDOJAW LARGE
• Common Device Name: FORCEPS, BIOPSY, ELECTRIC
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; tokyo 192-8 507; JA 192-8507
• MDR Report Key: 10325938
• Report Number: MW5095712
• Device Sequence Number: 14317407
• Product Code: KGE
• 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): 07/22/2020

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: FB225U
• Device Lot Number: 97V
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/24/2020
• 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