MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RADIAL JAW 4 LARGE CAPACITY WITH NEEDLE; FORCEPS, BIOPSY, NON-ELECTRIC

Model Number	M00513330
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Biopsy forcep noted by doctor during a procedure to have a piece of metal sticking out by the forcep tip.Discontinued use once noted and replaced item with a new one.Radial jaw with needle 2.8mm, lot # 28256175, exp 10/22/2024.Fda safety report id# (b)(4).

• Brand Name: RADIAL JAW 4 LARGE CAPACITY WITH NEEDLE
• Common Device Name: FORCEPS, BIOPSY, NON-ELECTRIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 13393794
• Report Number: MW5107070
• Device Sequence Number: 17312276
• Product Code: FCL
• UDI-Device Identifier: 08714729745549
• UDI-Public: (01)08714729745549
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 01/26/2022

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: 10/22/2024
• Device Model Number: M00513330
• Device Catalogue Number: M00513330
• Device Lot Number: 28256175
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/28/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown