MAUDE Adverse Event Report: BOSTON SCIENTIFIC BOSTON SCIENTIFIC RADIAL JAW 4 2.8 MM LARGE

Lot Number	19148700
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/24/2016
Type of Reportable Event	Malfunction
Event or Problem Description
During procedure (egd with mac anesthesia), esophageal specimens were being obtained.After obtaining a few specimens, doctor noted/stated the needle of the biopsy forceps was bent and requested another forceps.Old forceps was set aside and further biopsies obtained with new forceps per doctor without problem.Procedure was completed without incident.

• Brand Name: BOSTON SCIENTIFIC RADIAL JAW 4 2.8 MM LARGE
• Common Device Name: RADIAL JAW
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 5707093
• Report Number: MW5062736
• Device Sequence Number: 261043
• Product Code: FFF
• UDI-Device Identifier: 08714729745549
• UDI-Public: 08714729745549
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/27/2016

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 Lot Number: 19148700
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR