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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN BLADELESS VP 15MM ST W/ FIXATION; DISPOSABLE SURGICAL ACCESS DEVICE
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COVIDIEN BLADELESS VP 15MM ST W/ FIXATION; DISPOSABLE SURGICAL ACCESS DEVICE Back to Search Results
Model Number NB15STF
Device Problems Loss of or Failure to Bond (1068); Break (1069); Loose or Intermittent Connection (1371)
Patient Problems Hemorrhage/Bleeding (1888); Tissue Damage (2104)
Event Date 05/11/2015
Event Type  malfunction  
Event Description
Procedure: sleeve gastrectomy according to the reporter: the 5 mm reducer in the port is loose it can't be sealed properly.The seal is broken.There was no unanticipated tissue loss.The incision was not extended by more than one inch.There was no unanticipated blood loss of 500cc or more.Surgery time was not delayed by more than 30 minutes.No device fragment fell into the patient.
 
Manufacturer Narrative
(b)(4).
 
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Brand Name
BLADELESS VP 15MM ST W/ FIXATION
Type of Device
DISPOSABLE 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 Key4850727
MDR Text Key5808611
Report Number9612501-2015-00324
Device Sequence Number1
Product Code GCJ
Combination Product (y/n)N
Reporter Country CodeKU
PMA/PMN Number
K081169
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial
Report Date 06/16/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/30/2018
Device Model NumberNB15STF
Device Catalogue NumberNB15STF
Device Lot NumberJ3L1166X
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/16/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2013
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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