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

Model Number	M00513301
Medical Device Problem Codes	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	02/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.Device code a180104 captures the reportable event of that the material came with the presence of sharp material at the tip of the tweezers.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw was used during a stomach biopsy procedure performed on an unknown date.During preparation, a radial jaw had sharp material at the tip of the tweezers, which could cause mucosal laceration.The procedure was completed with another of the same device.No patient complications were reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw was used during a stomach biopsy procedure performed on an unknown date.During preparation, a radial jaw had sharp material at the tip of the tweezers, which could cause mucosal laceration.The procedure was completed with another of the same device.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block h6: device code a180104 captures the reportable event of that the material came with the presence of sharp material at the tip of the tweezers.Block h10: the returned trapezoid basket was analyzed, and a visual evaluation noted that the tail of the washer was out of place and bent.There were no indications of any foreign material present.The reported event was not confirmed.Based on all available information, it is possible that due to the manipulation or technique used at the time to remove the distal end cap could have pulled the tail of the washer out of place, then during the activation it bent.Therefore, the most probable root cause is adverse event related to procedure.A review of the manufacturing documentation for this reveled that no anomalies or deviations related to the event occurred during manufacturing.

• 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 IN ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16484381
• Report Number: 3005099803-2023-01035
• Device Sequence Number: 12177351
• Product Code: FCL
• UDI-Device Identifier: 08714729648758
• UDI-Public: 08714729648758
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2023

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: 08/11/2025
• Device Model Number: M00513301
• Device Catalogue Number: 1330-20
• Device Lot Number: 0029943408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/08/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown