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

Model Number	M00513332
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: this event was reported by the sales representative.The healthcare facility is: (b)(6).Block h6: imdrf device code a180104 captures the reportable event of foreign material present in device.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 large capacity forceps was used during an esophagogastroduodenoscopy procedure on (b)(6) 2024.During the procedure, it was reported that a plastic piece was attached to the cups of the biopsy forceps.The procedure was completed using another of the same device.There were no patient complications as a result of this event.Note: a photo of the device was provided by the account showing the device inside the patient with an unknown material attached to the cups.

• Brand Name: RADIAL JAW 4
• Common Device Name: FORCEPS, BIOPSY, NON-ELECTRIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19680511
• Report Number: 3005099803-2024-03229
• Device Sequence Number: 6835969
• Product Code: FCL
• UDI-Device Identifier: 08714729648826
• UDI-Public: 08714729648826
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/05/2024

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 Model Number: M00513332
• Device Catalogue Number: 1333-40
• Device Lot Number: 0032993295
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 07/05/2024
• Date Device Manufactured: 12/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown