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

Catalog Number M00515030

Device Problem Bent (1059)

Patient Problem No Information (3190)

Event Date 02/16/2017

Event Type  malfunction  

Event Description

As the physician was placing biopsy forcep through biopsy valve, one the hinged teeth of the forcep was bent, which left the device unusable.Another biopsy forcep was utilized without difficulty.Manufacturer response for biopsy forcep, radial jaw tm 4 (per site reporter): reported to complaint call center.Arrangements have been made to send product to manufacture via (b)(6).

• Brand Name: RADIAL JAW
• Type of Device: FORCEPS, BIOPSY, ELECTRIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 6493195
• MDR Text Key: 72806170
• Report Number: 6493195
• 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: 03/16/2017,03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: M00515030
• Device Lot Number: 19800529
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/16/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/16/2017
• 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
• Treatment: NO OTHER THERAPIES; OLYMPUS COLONSCOPE
• Patient Age: 64 YR
• Patient Weight: 120