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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 Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Additional attempts to obtain information and the device have been made. A supplemental report will be submitted with new details if they become available.
 
Event Description
According to the reporter, one of trocars was broken when package was opened.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
(b)(4). Post market vigilance (pmv) led an evaluation one device. The initial visual inspection of the sample by the pmv investigator noted the flexible sils port was not received. The cannula with the luer lock had a disengaged circular seal. Product analysis suggests the product was used in a surgical procedure. It is possible that the separation of the cap from the cannula is the result of rough handling. The product analysis concluded there were no device abnormalities that would have caused or contributed to the reported incident. No enhancements or improvements were generated for the reported condition. Should new information become available, the file will be re-opened and reassessed at that time.
 
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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
sharon murphy
60 middletown ave
north haven, CT 06473
2034925267
MDR Report Key5928907
MDR Text Key53941249
Report Number1219930-2016-00935
Device Sequence Number1
Product Code FER
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103253
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/11/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/06/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2020
Device Model NumberSILSPT12TA
Device Catalogue NumberSILSPT12TA
Device Lot NumberN5H0985X
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/12/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/08/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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