MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON; ANOSCOPE AND ACCESSORIES

Model Number SILSPT12TA

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 227 pilot program.(b)(4).None of the devices were reprocessed and reused.No remedial action was taken.

Event Description

This report summarizes 12 malfunction events which are associated with undesired damage or breakage of materials used in device construction.These reports were received from various sources.Patient information was confirmed for one event.(b)(6).

• Type of Device: ANOSCOPE AND ACCESSORIES
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 5612112
• MDR Text Key: 43800169
• Report Number: 1219930-2016-00384
• Device Sequence Number: 1
• Product Code: FER
• Combination Product (y/n): N
• Number of Events Reported: 12
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial

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?: No
• Device Operator: No Information
• Device Model Number: SILSPT12TA
• Device Catalogue Number: SILSPT12TA
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/27/2016
• Type of Device Usage: N
• Patient Sequence Number: 1