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

Model Number	M00513411
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 pediatric biopsy forceps was used during a gastroscopy and colonoscopy procedure on (b)(6) 2020.According to the complainant, during the procedure, the forceps were inserted into the working channel of the scope.Once the forceps were exposed at the distal tip of the scope, there was visible foreign matter on the screen that attached to the end of forceps.The forceps were removed from the patient but the foreign matter could not be retrieved.Following the removal of the gastroscope from the patient, a cleaning brush was inserted down the biopsy channel to expose any foreign matter in the cleaning room.A small amount of foreign matter was found visible.The cleaning brush tip was removed and placed in formalin to be sent to pathology.The pathology results could not conclusively determine if the material was human tissue or not.The patient also had a gastric polyp.It is considered possible that the polyp tissue may have been dislodged as the gastroscope was advanced.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
• MDR Report Key: 11141503
• Report Number: 3005099803-2020-06655
• Device Sequence Number: 10920608
• Product Code: FCL
• UDI-Device Identifier: 08714729777984
• UDI-Public: 08714729777984
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 01/08/2021

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: 07/24/2023
• Device Model Number: M00513411
• Device Catalogue Number: 1341
• Device Lot Number: 0025763325
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 01/08/2021
• Patient Sequence Number: 1