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). (b)(4) complaint was received during this report period. The 1 reported device is 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 the unintentional separation of the device and/or its components from something to which it is connected or attached. No patient information was confirmed.

• 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: 5611855
• MDR Text Key: 44467580
• Report Number: 1219930-2016-00381
• Device Sequence Number: 1
• Product Code: FER
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial

1 Device was Involved in the Event

0 Patients were 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

• Device Model Number: SILSPT12TA
• Device Catalogue Number: SILSPT12TA
• Was Device Available for Evaluation?: No Answer Provided

Was the Report Sent to FDA?

• Event Location: No Information
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage