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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN VERSAPORT V2 BLADELESS OPT 12; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

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COVIDIEN VERSAPORT V2 BLADELESS OPT 12; LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number ONB12STF
Device Problem Dull, Blunt (2407)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/07/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
According to the reporter, the physician mentioned to the nurse that the trocar was too dull to push through the fascia.
 
Manufacturer Narrative
Post market vigilance (pmv) led an evaluation of one device opened by the account.This evaluation was based on a technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends, and an evaluation of the returned device.Visual examination of the trocar assembly revealed the circular and envelope seals were intact.Functionally, the obturator was inserted into the trocar with no binding or difficulty.The obturator locking tabs functioned properly.The instrument was applied to test media; the blade tip penetrated cleanly and completely through the media, allowing the cannula to pass through.In addition, the trocar passed the air leak test.A review of the device history record indicates this device lot number was released meeting all medtronic quality specifications at the time of manufacture.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.
 
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Brand Name
VERSAPORT V2 BLADELESS OPT 12
Type of Device
LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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 Key5183571
MDR Text Key30064214
Report Number9612501-2015-00671
Device Sequence Number1
Product Code GCJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130435
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 01/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2020
Device Model NumberONB12STF
Device Catalogue NumberONB12STF
Device Lot NumberJ5H0348X
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/10/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/21/2015
Initial Date FDA Received10/28/2015
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received11/30/2015
01/19/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2015
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age30 YR
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