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

Model Number	179094F
Medical Device Problem Codes	Dull, Blunt (2407); Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer reference number: (b)(4).Since the lot number was not provided, this information cannot be determined.
Event or Problem 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.
Additional 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
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• MDR Report Key: 5786616
• Report Number: 9612501-2016-00262
• Device Sequence Number: 640342
• Product Code: GCJ
• UDI-Device Identifier: 20884521081274
• UDI-Public: 20884521081274
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K062326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/12/2016
• Supplement Report FDA Received Date: 09/26/2016
• Patient Sequence Number: 1