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

Model Number	M00513441
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw biopsy forceps was to be used in a biopsy procedure performed on (b)(6) 2022.During the procedure, the forceps' midsection and tip had what appeared to be a bit of metal attached to it.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Device code a180104 captures the reportable event of foreign material present in device.The returned radial jaw4 was analyzed, and a visual evaluation noted that the handle and jacket were observed to be in good condition.There were no foreign objects attached and the jaws were in good shape.The washer tail and pull wires were positioned correctly and no signs of foreign materials could be seen when viewed under a microscope.The incident was confirmed by a photo the customer gave, which showed a silky thread that is not a part of the device.The customer's images show a smooth thread-like material in the jaws.However, because the device has been removed from its original packaging, it is impossible to say whether the observed material was present when the customer received the product, and the cause of how the foreign material got there cannot be determined.Furthermore, the analysis of the returned device revealed no evidence of foreign materials.Based on the available information, "no problem detected" was chosen as the most likely cause of this complaint.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw biopsy forceps was to be used in a biopsy procedure performed on (b)(6), 2022.During the procedure, the forceps' midsection and tip had what appeared to be a bit of metal attached to it.There were no patient complications reported as a result of 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: 16045790
• Report Number: 3005099803-2022-07696
• Device Sequence Number: 15019202
• Product Code: FCL
• UDI-Device Identifier: 08714729789918
• UDI-Public: 08714729789918
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2023

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: 06/02/2025
• Device Model Number: M00513441
• Device Catalogue Number: 1344
• Device Lot Number: 0029522498
• 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: 12/05/2022
• Supplement Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 12/24/2022
• Supplement Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2022
• 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