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

Model Number	M00513411
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Tissue Damage (2104)
Date of Event	11/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, 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 with needle was used in a biopsy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, it was noted that the forceps did not cleanly take a bite but was tearing excess tissue.The procedure was completed with this device and the patient was discharged.On the same day, the patient experience bleeding and returned to the hospital.The patient went to the accident and emergency (a&e) department but was not admitted to the ward.On the next day, the patient experienced a small amount of bleeding and returned to a&e.Reportedly, no treatment for the bleeding was performed at a&e.

• 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: 11041352
• Report Number: 3005099803-2020-06051
• Device Sequence Number: 1265779
• Product Code: FCL
• UDI-Device Identifier: 08714729777984
• UDI-Public: 08714729777984
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 12/18/2020

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 Expiration Date: 09/03/2023
• Device Model Number: M00513411
• Device Catalogue Number: 1341
• Device Lot Number: 0025960884
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/23/2020
• Initial Report FDA Received Date: 12/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization