MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON SILSPORT 12 TEM INDICATION; 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

This report is being submitted under alternative summary reporting exemption (b)(4).This summary report is part of the 227 pilot program.Two complaints were received during this report period.Of these, 1 was not returned for evaluation.One was determined to be misapplication.Both reported devices are labeled for single use.None of the devices were reprocessed and reused.No remedial action was taken.

Event Description

This report summarizes 2 malfunction events which are associated with the unintentional separation of the device and/or its components from something to which it is connected or attached.These reports were received from various sources.Patient information was not confirmed for either event.

• Brand Name: SILSPORT 12 TEM INDICATION
• 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: matthew amaral ; 60 middletown ave; north haven, CT 06473 ; 2034926373
• MDR Report Key: 5830908
• MDR Text Key: 51734018
• Report Number: 1219930-2016-00759
• Device Sequence Number: 1
• Product Code: FER
• Combination Product (y/n): N
• Number of Events Reported: 2
• 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

• Date FDA Received: 07/28/2016
• 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
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1