MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BOSTON SCIENTIFIC BIOPSY FORCEPS; FORCEPS, BIOPSY, NON-ELECTRIC

Model Number	08714729745549
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
During egd procedure the needle tip of the forcep broke off in pt's esophagus.No apparent injury at time of procedure.Fda safety report id# (b)(4).

• Brand Name: BOSTON SCIENTIFIC BIOPSY FORCEPS
• Common Device Name: FORCEPS, BIOPSY, NON-ELECTRIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 10975640
• Report Number: MW5098258
• Device Sequence Number: 752796
• Product Code: FCL
• UDI-Device Identifier: 08714729745549
• UDI-Public: 01087147297455491723092510260813
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/04/2020

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: 09/25/2023
• Device Model Number: 08714729745549
• Device Catalogue Number: 90402821-04
• Device Lot Number: 26081385
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/08/2020
• 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
• Patient Age: 41 YR