MAUDE Adverse Event Report: COVIDIEN; GOUGE, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number 179775P

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This summary report is part of the (b)(6).One complaint was received during this report period.One was determined to be the result of manufacturing error the reported device was labeled for single use.The device was not reprocessed and reused.No remedial action was taken.

Event Description

This report summarizes 1 malfunction event which is associated with undesired damage or breakage and disengagement of materials used in device construction.Patient information was not confirmed for this event.

• Type of Device: GOUGE, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer (Section G): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 5611293
• MDR Text Key: 44558151
• Report Number: 9612501-2016-00081
• Device Sequence Number: 1
• Product Code: GDH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 179775P
• Device Catalogue Number: 179775P
• Type of Device Usage: N
• Patient Sequence Number: 1