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

Model Number	ONB12LGF
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
According to the reporter, during a thyroid lobectomy, the self adjusting seal was broken.The device was not used on the patient.
Additional Manufacturer Narrative
(b)(4).Post market vigilance (pmv) led an evaluation of one versaport v2 opt bladeless 12 long 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.The reported condition for this incident was that during a thyroid lobectomy the seal was damaged.The visual inspection of the device noted that the locking tabs on the 12mm head and the trocar were broken.Functional testing was precluded due to the observed damage.Visual testing of the returned product confirmed the product did not meet quality release specifications that were tested regarding the reported conditions due to the damaged locking tabs.A review of the current historical complaint data reveals no trend for a device related failure for this condition.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.

• Brand Name: VERSAPORT V2 OPT BLADELESS 12 LONG
• 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: 5783683
• Report Number: 9612501-2016-00258
• Device Sequence Number: 18995666
• Product Code: GCJ
• UDI-Device Identifier: 10884521181342
• UDI-Public: (01)10884521181342(17)201231(10)J5M0515X
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K130435
• 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,Followup
• Report Date (Section B): 06/23/2016

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 Expiration Date: 12/31/2020
• Device Model Number: ONB12LGF
• Device Catalogue Number: ONB12LGF
• Device Lot Number: J5M0515X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/23/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/11/2016
• Supplement Report FDA Received Date: 08/08/2016; 10/06/2016
• Patient Sequence Number: 1