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

Model Number	M00513411
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Open or Close (2921); Device Contamination with Chemical or Other Material (2944); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received for analysis, 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 biopsy forceps was used in the colon during a biopsy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the forceps got stuck inside the scope and the procedure was discontinued.Once the forceps was removed from the scope, one side of the jaws was found to be opened and a black vinyl was noted stuck on the jaw's teeth.It was suspected that the scope was damaged and was sent for repair.The scope was inspected and it was confirmed that the black vinyl like object was not from the internal lumen of scope.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: device code 2944 captures the reportable event of foreign material present in device.Block h10: visual analysis of the returned device found foreign matter on the tip of the jaws.The jaws are aligned properly.Functional inspection found the jaws opened and closed within specifications.The foreign matter was sent for analysis and is a match of at least 92% to alginic acid.Based on the information available, the foreign matter found could had been acquired during the procedure since the issue occurred during the procedure and inside the patient.Therefore, the most probable cause for this complaint is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly, and performance specifications at the time of release for distribution.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 biopsy forceps was used in the colon during a biopsy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the forceps got stuck inside the scope and the procedure was discontinued.Once the forceps was removed from the scope, one side of the jaws was found to be opened and a black vinyl was noted stuck on the jaw's teeth.It was suspected that the scope was damaged and was sent for repair.The scope was inspected and it was confirmed that the black vinyl like object was not from the internal lumen of scope.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: 8575503
• Report Number: 3005099803-2019-02353
• Device Sequence Number: 14077253
• Product Code: FCL
• UDI-Device Identifier: 08714729777984
• UDI-Public: 08714729777984
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2019

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: 09/28/2021
• Device Model Number: M00513411
• Device Catalogue Number: 1341
• Device Lot Number: 0022722646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Initial Date Received by Manufacturer: 04/09/2019
• Supplement Date Received by Manufacturer: 06/06/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 07/02/2019
• Patient Sequence Number: 1