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

Model Number	FB-210U
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	10/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product was not returned for evaluation as the user discarded the subject device after use.If additional information becomes available this report will be supplemented accordingly.
Event or Problem Description
It was reported that during an endoscopy procedure, the forceps did not come out of the sheath properly.Customer confirmed that the event caused a large tear in ¿esophagus¿ that required a clip closure.The intended procedure was completed.There was no other device replaced during the procedure and the subject device was not returning as it was discarded by the customer after use.

• 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: 9199342
• Report Number: 8010047-2019-03607
• Device Sequence Number: 448027
• Product Code: FCL
• UDI-Device Identifier: 04953170354113
• UDI-Public: 04953170354113
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K955065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: FB-210U
• Device Lot Number: 8ZV
• 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: 10/02/2019
• Initial Report FDA Received Date: 10/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention