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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN BLADELESS VP 15MM LG W/ FIXATION DISPOSABLE SURGICAL ACCESS DEVICE

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COVIDIEN BLADELESS VP 15MM LG W/ FIXATION DISPOSABLE SURGICAL ACCESS DEVICE Back to Search Results
Model Number NB15LGF
Device Problems Valve(s) (527); Component Falling (1105)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Event Description

According to the reporter: on use valve fell off. Did the difficulty result in unintended colostomy, formal laparotomy, re-operation etc. : no there was no unanticipated tissue loss. There was no unanticipated tissue damage. There was no unanticipated blood loss of more than 250cc and no delay over 30 minutes. No device fell in patients cavity and no device fragment left in patient.

 
Manufacturer Narrative

(b)(4). Initial report sent to fda on 02/26/2015.

 
Manufacturer Narrative

(b)(4).

 
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Brand NameBLADELESS VP 15MM LG W/ FIXATION
Type of DeviceDISPOSABLE SURGICAL ACCESS DEVICE
Manufacturer (Section D)
COVIDIEN
zona franca de san isidro
carretara san isidro km17
santo domingo
DR
Manufacturer (Section G)
COVIDIEN
zona franca de san isidro
carretara san isidro km17
santo domingo
DR
Manufacturer Contact
sharon murphy
60 middletown ave
north haven, CT 06473
2034925267
MDR Report Key4551588
MDR Text Key5516006
Report Number9612501-2015-00112
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK081169
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/19/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/26/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberNB15LGF
Device Catalogue NumberNB15LGF
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/05/2015
Is The Reporter A Health Professional? No
Date Manufacturer Received02/19/2015
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Type of Device Usage Unkown

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