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

Model Number	M00515030
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/03/2020
Event or Problem Description
The surgeon stated that the clamp/ jaw portion of the forceps bent while inside of the patient, the forceps and endoscope was then removed from the patient.The clamp/ jaw of the forceps had to be broken in order to remove the device from the endoscope.

• Brand Name: RADIAL JAW 4
• Common Device Name: FORCEPS, BIOPSY, ELECTRIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 10004672
• Report Number: 10004672
• Device Sequence Number: 11450663
• Product Code: KGE
• UDI-Device Identifier: 08714729821700
• UDI-Public: (01)08714729821700
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/21/2020
• Report Date (Section F): 04/21/2020

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?: No
• Operator of Device: No Information
• Device Model Number: M00515030
• Device Catalogue Number: M00515030
• Device Lot Number: 24297043
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/28/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 51
• Date Report Sent to FDA: 04/21/2020