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

Model Number	M00513401
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	09/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a1802 captures the reportable event of hair found in packaging.
Event or Problem Description
It was reported to boston scientific corporation that a hair was found in the radial jaw 4 standard capacity biopsy forceps packaging on (b)(6) 2024.During unpacking, a hair appears to be caught in the crimped part of the packaging.The packaging has not been opened.It is unclear whether the sterility was compromised or not.There was no patient involved in this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a1802 captures the reportable event of hair found in packaging.Block h11: the returned radial jaw 4 sc biopsy forceps was analyzed, and a visual inspection observed the pouch had a foreign material caught in the crimped part of the packaging.The pouch was unopen.The reported event of packaging foreign matter was confirmed.Based on all available information, the most probable root cause is manufacturing deficiency.An investigation to address this problem is in progress.
Event or Problem Description
It was reported to boston scientific corporation that a hair was found in the radial jaw 4 standard capacity biopsy forceps packaging on (b)(6) 2024.During unpacking, a hair appears to be caught in the crimped part of the packaging.The packaging has not been opened.It is unclear whether the sterility was compromised or not.There was no patient involved in 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; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20304885
• Report Number: 3005099803-2024-04716
• Device Sequence Number: 12694350
• Product Code: FCL
• UDI-Device Identifier: 08714729777960
• UDI-Public: 08714729777960
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 11/14/2024

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: M00513401
• Device Catalogue Number: 1340
• Device Lot Number: 0033184659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2024
• 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