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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). 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).
 
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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 Key5612112
MDR Text Key43800169
Report Number1219930-2016-00384
Device Sequence Number1
Product Code FER
Combination Product (y/n)N
Number of Events Reported12
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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