MAUDE Adverse Event Report: COVIDIEN VERSAPORT V2 FIXATION CANNULA 5MM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 179094F

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/27/2016

Event Type  malfunction  

Manufacturer Narrative

Manufacturer reference number: (b)(4).Since the lot number was not provided, this information cannot be determined.

Event Description

According to the reporter, during a donor nephrectomy, at the first usage there were difficulties while entering to the abdomen and the device could not cut.There is no problem related cannula.Knife/cutter did not cut.

Manufacturer Narrative

(b)(4).Post market vigilance (pmv) and concurrently with engineering led an evaluation of five trocars with fixation cannula opened by the account.Visual inspection noted the five obturators were received heat damaged.The tops of the obturators were not seated properly.A trocar was received.Functionally, the condition of the instrument precludes functional testing.Replication of the observed heat damage may occur if the instrument is subjected to excessive heat during a sterilization process.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.

• Brand Name: VERSAPORT V2 FIXATION CANNULA 5MM
• 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: 5786616
• MDR Text Key: 49303218
• Report Number: 9612501-2016-00262
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 20884521081274
• UDI-Public: 20884521081274
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 179094F
• Device Catalogue Number: 179094F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/27/2016
• Initial Date FDA Received: 07/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1