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

Model Number	1340
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	07/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 was intended for use in a procedure on (b)(6) 2025.Prior to unpacking the device, the outer bag was checked and an oily stain was noticed on the label near the protective cap at the tip of the cup.The oily blotch was also noted inside the packaging on the device.The procedure was completed with another of same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
H6: device code a180104 captures the reportable event of foreign material present in device.
Additional Manufacturer Narrative
Block h6: device code a180104 captures the reportable event of foreign material present in device.Block h11: the returned radial jaw 4 was analyzed, and a visual inspection found the pouch was unopened and the label had an oily stain mark.Based on all available information, the reported problem of oily stain on the label should have been detected during the manufacturing process according to the procedure "92021606, boxing and box label application, bsc", which explains that the device must be scrapped if this happen.However, it is not possible to know if the pouch got this greasy stain during storage, transport, manufacturing process or during the preparation.Therefore, this is not clear what could affect the pouch.Manufacturing records were reviewed and no deviations within the manufacturing processes were found.Therefore, the most probable conclusion code is cause not established as there is no evidence to identify the root of the oily stain found in the pouch.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 was intended for use in a procedure on (b)(6) 2025.Prior to unpacking the device, the outer bag was checked and an oily stain was noticed on the label near the protective cap at the tip of the cup.The oily blotch was also noted inside the packaging on the device.The procedure was completed with another of same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: device code a180104 captures the reportable event of foreign material present in device.Correction block h11: the returned radial jaw 4 was analyzed, and a visual inspection found the pouch was unopened and the label had an oily stain mark, there was foreign material; however, it was not inside the pouch.An investigation to address this problem is in progress.Based on all available information, the reported problem of oily stain on the label should have been detected during the manufacturing process according to the procedure (b)(6) boxing and box label application, bsc", which explains that the device must be scrapped if this happens.However, it is not possible to know if the pouch got this greasy stain during storage, transport, manufacturing process or during the preparation.Therefore, this is not clear what could affect the pouch.Manufacturing records were reviewed and no deviations within the manufacturing processes were found.Therefore, the most probable conclusion code is cause not established as there is no evidence to identify the root of the oily stain found in the pouch.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 was intended for use in a procedure on (b)(6) 2025.Prior to unpacking the device, the outer bag was checked and an oily stain was noticed on the label near the protective cap at the tip of the cup.The oily blotch was also noted inside the packaging on the device.The procedure was completed with another of same device.There were no patient complications 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 22753006
• Report Number: 3005099803-2025-03942
• Device Sequence Number: 15632312
• Product Code: FCL
• UDI-Device Identifier: 08714729777960
• UDI-Public: (01)08714729777960(17)271205(10)35422830
• 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,Followup
• Report Date (Section B): 01/07/2026

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: 1340
• Device Catalogue Number: 1340
• Device Lot Number: 0035422830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2025
• Supplement Date Received by Manufacturer: 09/03/2025; 12/10/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 09/25/2025; 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2024
• 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