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

Model Number	51309
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf impact code f2202 captures the reportable event of the endoscopic procedure bronchoscopy.Block h11: the returned radial jaw 4 was analyzed, and a visual and microscope inspection found the jaws and needle detached.Media inspection of the picture provided shows the jaws and needle detached.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of "adverse event related to procedure".This conclusion was selected because during the product analysis the device returned with the jaws and needle detached.Due to this condition, it is not possible to analyze these two components.Also, operational factors such as the size of the desired biopsy and the force applied to the device in order to grasp the tissue could have caused the analyzed failures.The force applied to the handle to grasp the tissue could generate tension on the distal section (jaws), which may have contributed to the observed damage.Excessive manipulation of the device in or out of its pouch without sufficient care could also have contributed to the defects identified.Regarding the reported allegation "needle detached/separated", this issue was confirmed during the visual inspection of the device.On the other hand, the event "endoscopic procedure" cannot be confirmed because it happened during the procedure and there is no objective evidence or descriptive condition to establish the cause of the reported event.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications, however there is no control how the devices are handled/manipulated in the field.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 was used in the stomach during a esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2026.During the procedure, at the second biopsy attempt, the metal jaws of the biopsy forceps disengaged from the catheter and broke off into the patient.A bronchoscopy was performed to ensure no pieces were aspirated into the airway.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; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 24505427
• Report Number: 3005099803-2026-00820
• Device Sequence Number: 13376060
• Product Code: FCL
• UDI-Device Identifier: 08714729778004
• UDI-Public: (01)08714729778004(17)281008(10)37668978
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 51309
• Device Catalogue Number: 51309
• Device Lot Number: 0037668978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown