MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORP RADIAL JAW LARGE CAPACITY WITH NEEDLE; FORCEPS, BIOPSY

Catalog Number M00513330

Device Problems Bent (1059); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/20/2016

Event Type  malfunction  

Event Description

A radial jaw biopsy forceps was being used for an upper endoscopy with fluoro and dilation.It worked the first time it was used and after being reinserted the jaws appeared bent and wound not close.Another forceps was used to complete the procedure.The patient was not harmed.

• Brand Name: RADIAL JAW LARGE CAPACITY WITH NEEDLE
• Type of Device: FORCEPS, BIOPSY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORP; 300 boston scientific way; marlborough, MA 01752
• MDR Report Key: 5678123
• MDR Text Key: 45878134
• Report Number: 5678123
• Device Sequence Number: 1
• Product Code: KGE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/05/2019
• Device Catalogue Number: M00513330
• Device Lot Number: 18995575
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/09/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 05/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17 YR