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

Model Number	M00515031
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a1802 captures the reportable event of packaging foreign matter.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 hot biopsy forceps was to be used during an unknown procedure on (b)(6) 2024.During unpacking, a hair-like object was found inside the bag before opening the sterile package.The procedure was completed with a non-bsc device.There was no patient involved in this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a1802 captures the reportable event of packaging foreign matter.Block h10: investigation results the returned radial jaw 4 hot biopsy forceps device was analyzed with the original pouch unopened, and a black particle was found inside the packaging.The reported event of packaging foreign matter was confirmed; however, it was inside the tolerance of 1.00mm^2 mm, 3 or less foreign materials as it was measured at.30mm^2.Based on all available information, no problem detected was selected as the most probable cause due to the device being 100% inspected for foreign material.The analysis of the available information, product analysis of the returned device, and product record review did not identify any evidence of either the alleged issues or any defect on the device.Also, the evidence from the product record review did not identify a potential product quality issue or new patient harm.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 hot biopsy forceps was to be used during an unknown procedure on (b)(6) 2024.During unpacking, a hair-like object was found inside the bag before opening the sterile package.The procedure was completed with a non-bsc device.There was no patient involved in this event.

• Brand Name: RADIAL JAW 4
• Common Device Name: FORCEPS, BIOPSY, 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: 18627867
• Report Number: 3005099803-2024-00220
• Device Sequence Number: 12734888
• Product Code: KGE
• UDI-Device Identifier: 08714729790136
• UDI-Public: 08714729790136
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101657
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2024

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: 08/20/2023
• Device Model Number: M00515031
• Device Catalogue Number: 1503
• Device Lot Number: 0025890767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2024
• Supplement Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2020
• 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