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U.S. Department of Health and Human Services

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

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COVIDIEN, FORMERLY US SURGICAL A DIVISON SILSPORT 12 TEM INDICATION ANOSCOPE AND ACCESSORIES Back to Search Results
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.
 
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Brand NameSILSPORT 12 TEM INDICATION
Type of DeviceANOSCOPE 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 Key5830908
MDR Text Key51734018
Report Number1219930-2016-00759
Device Sequence Number1
Product Code FER
Combination Product (y/n)N
Number of Events Reported2
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 Received07/28/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model NumberSILSPT12TA
Device Catalogue NumberSILSPT12TA
Was Device Available for Evaluation? No
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

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