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U.S. Department of Health and Human Services

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

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COVIDIEN, FORMERLY US SURGICAL A DIVISON 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
(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.
 
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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
sharon murphy
60 middletown ave
north haven, CT 06473
2034925267
MDR Report Key5611855
MDR Text Key44467580
Report Number1219930-2016-00381
Device Sequence Number1
Product Code FER
Combination Product (y/n)N
Number of Events Reported1
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 Received04/27/2016
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 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

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