MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RADIAL JAW; FORCEPS

Lot Number 16995416

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2014

Event Type  malfunction  

Event Description

During proximal esophageal biopsy, radial jaw forcep (lot #16995416) (boston scientific) a piece of metal came off during biopsy and was visible in the esophagus.Piece of metal was able to be removed with the forcep and no visible injury occurred.

• Brand Name: RADIAL JAW
• Type of Device: FORCEPS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 4216694
• MDR Text Key: 4975485
• Report Number: 4216694
• Device Sequence Number: 1
• Product Code: BWH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Lot Number: 16995416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/15/2014
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2014
• Patient Sequence Number: 1