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

Model Number	M00513401
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	12/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device problem code a180104 captures the reportable event of "gauze appeared to have black stains".
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 standard capacity forceps was to be used during a tissue biopsy on (b)(6) 2023.During preparation, the nurse wiped the radial jaw 4 forceps with a wet gauze and found black marks on it.The doctor felt uncomfortable using it and decided not to use the product.Another radial jaw 4 was used to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device problem code a180104 captures the reportable event of "gauze appeared to have black stains".Block h10: the returned radial jaw 4 standard capacity biopsy forceps was analyzed, and a visual inspection observed there were no damages on the device.During the product analysis a wipe was passed along the working length, and the wipe was stained with black ink from the radiopaque markers printed on the device.Media inspection observed the device was inside the pouch with the stained gauze.A labeling review was performed and, from the information available, this device was used in a manner inconsistent with the instructions for use (ifu) / product label.It was reported that the radial jaw 4 forceps was wiped with a wet gauze and found black marks on it, however the ifu does not include a step in which the device should be cleaned in this manner.Therefore, the event is catalogued as unintended use error caused or contributed to event.The current process flow for the radial jaw 4 product is performing a 100% cleaning on the coil prior to inserting the unit into the pouch.In this cleaning process, it's also ensured the cleaning effectiveness which uses a wipe with qualified ipa (alcohol) to clean the coil.This cleaning is an automated process that uses 1 wipe per unit.If the customer used any other solution, that could have caused the ink to create that condition.Based on all available information, the investigation conclusion code for the reported event of foreign material present in device is no problem detected as the black radiopaque marks are part of the design.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 standard capacity forceps was to be used during a tissue biopsy on (b)(6) 2023.During preparation, the nurse wiped the radial jaw 4 forceps with a wet gauze and found black marks on it.The doctor felt uncomfortable using it and decided not to use the product.Another radial jaw 4 was used to complete the procedure.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: 18495656
• Report Number: 3005099803-2023-07097
• Device Sequence Number: 6984931
• Product Code: FCL
• UDI-Device Identifier: 08714729777960
• UDI-Public: 08714729777960
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 03/20/2024

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 Expiration Date: 05/24/2026
• Device Model Number: M00513401
• Device Catalogue Number: 1340
• Device Lot Number: 0031688881
• 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: 12/20/2023
• Supplement Date Received by Manufacturer: 02/23/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2023
• 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