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

Model Number	M00513391
Medical Device Problem Codes	Difficult to Remove (1528); Material Twisted/Bent (2981); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The returned radial jaw 4 sc forceps was analyzed, and found the clevis arm bent.It was returned with the handle and the hypotube cut off.Photos were also provided and found the clevis arm bent.No other visual damage was noted.The reported event of clevis arms bent was confirmed.Based on all available information, it is possible that during attempts to remove the device an excessive force was applied to the device which resulted in clevis arm bent.Forcing the device against significant resistance could result in device damage or loss of functionality.There is no evidence of a manufacturing issue, design or user issue which could have caused the complaint.Upon product analysis the device was received with the handle and hypotube cut, which was mentioned in the complaint and is consistent with a force being applied during removal from the scope.No defects were reported with the device before being utilized.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 standard capacity biopsy forceps was used in the stomach during an endoscopic biopsy procedure performed on (b)(6) 2021.During the procedure, when the forceps was tried to be pulled out on the fourth biopsy, the forceps got stuck in the endoscope.The handle was cut and the catheter was pulled by hand to remove the device from the scope.The scope could no longer be used; therefore, the procedure was aborted.A photo submitted by the customer showed that the clevis arms was bent.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
• MDR Report Key: 12198351
• Report Number: 3005099803-2021-03634
• Device Sequence Number: 1493662
• Product Code: FCL
• UDI-Device Identifier: 08714729777977
• UDI-Public: 08714729777977
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/20/2021

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: 11/05/2023
• Device Model Number: M00513391
• Device Catalogue Number: 1339
• Device Lot Number: 0026298669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 07/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1