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	03/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 pulmonary was used in a pulmonary biopsy procedure performed on an unknown date.During the procedure, the jaws failed to close on the second pass.A different device was used to complete the procedure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a051104 captures the reportable event of jaws failure to close.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a051104 captures the reportable event of jaws failure to close.Block h11: the returned radial jaw 4 pulmonary biopsy forceps was analyzed, and a visual inspection observed the jaws were opening uneven.Microscope inspection observed one pull wire seems to be stuck to the washer, restricting the capabilities of opening the jaws.The reported event of jaws failure to close was confirmed.Based on all available information, the manipulation or technique used to remove the distal end cap could have pulled the pull wire out of place, then it got stuck into the washer during the activation.Therefore, the most probable root cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 pulmonary was used in a pulmonary biopsy procedure performed on an unknown date.During the procedure, the jaws failed to close on the second pass.A different device 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, 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: 19105551
• Report Number: 3005099803-2024-01668
• Device Sequence Number: 15418505
• Product Code: BWH
• UDI-Device Identifier: 08714729792864
• UDI-Public: 08714729792864
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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,Followup
• Report Date (Section B): 06/20/2024

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: M00515181
• Device Catalogue Number: 1518
• Device Lot Number: 0032677398
• 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: 03/24/2024
• Supplement Date Received by Manufacturer: 05/27/2024
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2023
• 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