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

Model Number	M00513381
Medical Device Problem Codes	Difficult to Open or Close (2921); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 standard capacity biopsy forceps was used during a gastrointestinal biopsy procedure performed on (b)(6) 2021.During the procedure, the forceps failed to close on the third biopsy and could not be removed from the scope.The forceps were cut so they could be removed from the scope.The procedure was not completed and there is no information on wether the patient has rescheduled for another biopsy.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: medical device problem code a27 is being used to capture the reportable event of aborted/cancelled procedure.Block h10: the returned radial jaw 4 biopsy forceps was analyzed, and a visual evaluation noted that the clevis arm was returned cut and it was bent.No other issues with the device were noted.The reported event 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 results in clevis arms bent.Forcing the device against significant resistance could result in device damage or loss of functionality.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 during a gastrointestinal biopsy procedure performed on (b)(6) 2021.During the procedure, the forceps failed to close on the third biopsy and could not be removed from the scope.The forceps were cut so they could be removed from the scope.The procedure was not completed and there is no information on wether the patient has rescheduled for another biopsy.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: 12062887
• Report Number: 3005099803-2021-02943
• Device Sequence Number: 3502589
• Product Code: FCL
• UDI-Device Identifier: 08714729777953
• UDI-Public: 08714729777953
• 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,Followup
• 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: 08/06/2023
• Device Model Number: M00513381
• Device Catalogue Number: 1338
• Device Lot Number: 0025818797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 06/24/2021
• Supplement 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