MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RADIAL JAW 4; FORCEPS, BIOPSY, BRONCHOSCOPE (NON-RIGID)

Model Number	M00515181
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a051104 captures the reportable event of jaws failure to close.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 pulmonary forceps was used during a thoracoscopic biopsy procedure on (b)(6) 2024.During the procedure, the forceps could not be closed, and biopsy could not be extracted normally.The procedure was completed using another radial jaw 4 pulmonary forceps.There are no known patient complications as a result of this event.

• Brand Name: RADIAL JAW 4
• Common Device Name: FORCEPS, BIOPSY, BRONCHOSCOPE (NON-RIGID)
• 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: 19950075
• Report Number: 3005099803-2024-03787
• Device Sequence Number: 8966801
• Product Code: BWH
• UDI-Device Identifier: 08714729792864
• UDI-Public: 08714729792864
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/09/2024

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 Expiration Date: 08/06/2026
• Device Model Number: M00515181
• Device Catalogue Number: 1518
• Device Lot Number: 0032166381
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2024
• Initial Report FDA Received Date: 08/09/2024
• Date Device Manufactured: 08/07/2023
• 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 Age: 55 YR
• Patient Sex: Male