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

Model Number	M00513402
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	09/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 standard capacity forceps was used during an endoscopic biopsy procedure performed on (b)(6) 2023.During the procedure, a wire was noticed at the base of the jaws when the nurse was retrieving the biopsy samples outside of the patient.The wire was pulled off the device with non-biopsy forceps.No fragments were reported, and nothing detached inside the patient.It is unknown where the wire came from and if it is a component of the device.At this point, the biopsy portion was already completed, and the procedure was completed successfully.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a180104 captures the reportable event of foreign material present in the device.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 standard capacity forceps was used during an endoscopic biopsy procedure performed on (b)(6) 2023.During the procedure, a wire was noticed at the base of the jaws when the nurse was retrieving the biopsy samples outside of the patient.The wire was pulled off the device with non-biopsy forceps.No fragments were reported, and nothing detached inside the patient.It is unknown where the wire came from and if it is a component of the device.At this point, the biopsy portion was already completed, and the procedure was completed successfully.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h2: the content in block d5 (operator of device) has been corrected.Block h6: imdrf device code a180104 captures the reportable event of foreign material present in the device.Block h10: the radial jaw 4 device was not returned; however, a piece of metal was returned for analysis.A media inspection of the photo provided by the customer also showed a piece of metal.With all the available information, boston scientific confirmed the reported clinical observations.The most probable root cause is likely a deficiency within the manufacturing process.An investigation to address this problem is in progress.

• 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: 17886103
• Report Number: 3005099803-2023-05350
• Device Sequence Number: 6976377
• Product Code: FCL
• UDI-Device Identifier: 08714729778028
• UDI-Public: 08714729778028
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2023

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: 05/02/2026
• Device Model Number: M00513402
• Device Catalogue Number: 51475
• Device Lot Number: 0031547446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2023
• 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