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

Model Number	M00513362
Medical Device Problem Codes	Break (1069); Device Contamination with Chemical or Other Material (2944); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a180104 captures the reportable event of a white plastic piece was seen.
Event or Problem Description
It was reported to boston scientific corporation that were a radial jaw was used in the colon on a biopsy procedure performed on (b)(6) 2023.During procedure, a wire was observed extending from the side of the forceps, along with a white plastic piece.Another trapezoid rx basket was used to complete the procedure.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 a white plastic piece was seen.Block h10: the returned radial jaw 4 was analyzed and there was no evidence of foreign material.Visual inspection found that the jacket was cut, and the tail of the washer was out of place and bent.With all the available information, boston scientific concludes the reported event of foreign material was not confirmed.However, the reported observation of ''wire extending from the side of the forceps'' was confirmed as the washer tail was bent.It is possible that when the distal cap was removed, the tail of the washer was forced out of place.Additionally, the manipulation during the procedure, the technique used, or the patient's anatomic conditions could have contributed to the washer tail becoming bent.It was also found that the jacket of the device was cut, likely to remove the device from the scope.Therefore, the most probable cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that were a radial jaw was used in the colon on a biopsy procedure performed on (b)(6) 2023.During procedure, a wire was observed extending from the side of the forceps, along with a white plastic piece.Another trapezoid rx basket was used to complete the procedure.There were no patient complications as a result of this event.

• 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: 17672664
• Report Number: 3005099803-2023-04631
• Device Sequence Number: 6434999
• Product Code: FCL
• UDI-Device Identifier: 08714729648888
• UDI-Public: 08714729648888
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2023

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: 05/22/2026
• Device Model Number: M00513362
• Device Catalogue Number: 1336-40
• Device Lot Number: 0031671244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2023
• Supplement Date Received by Manufacturer: 09/04/2023
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2023
• 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