MAUDE Adverse Event Report: COVIDIEN VERSAPORT PLUS V2 11MM TROCAR W/FIXATION CANNULA; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 179095PF

Device Problems Dull, Blunt (2407); Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, during first use there were difficulties while entering the abdomen and the device could not cut.There was no problem related cannula.Knife/cutter did not cut.

Manufacturer Narrative

(b)(4).Post market vigilance (pmv) (concurrently with engineering) led an evaluation of five versaport plus v2 11mm trocars with fixation cannula 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, engineering review of the photos and an evaluation of the returned device.The reported condition for this incident states difficult to penetrate, no cut and knife blade dull.Visual inspection noted the five obturators were received heat damaged.The tops of the obturators were not seated properly.Functionally, the condition of the instrument precludes functional testing.Visual inspection of the returned product confirmed the product did not meet quality release specifications that were tested regarding the reported conditions due to the heat damage and the reported condition was not confirmed.A review of the current historical complaint data reveals no trend for a device related failure for this condition.Based on the product analysis, the failure was not confirmed to be attributed to the reported event.Replication of the observed heat damage may occur if the instrument is subjected to excessive heat during a sterilization process.No enhancements or improvements were generated for the reported condition.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.

• Brand Name: VERSAPORT PLUS V2 11MM TROCAR W/FIXATION CANNULA
• 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 Key: 5786997
• MDR Text Key: 49313411
• Report Number: 9612501-2016-00265
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K062326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 179095PF
• Device Catalogue Number: 179095PF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1