MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON VERSAPORT V2 OPT BLADELESS 12 SHORT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number ONB12SHF

Device Problems Difficult to Insert (1316); Activation, Positioning or Separation Problem (2906); Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/22/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter: during a laparoscopic low anterior resection procedure, the obturator was attempted to insert through the cannula.However, the lower seal did not open and the obturator was unable to penetrate it.

Manufacturer Narrative

Evaluation summary: 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, an a pmv review of complaint trends, and an evaluation of the returned device.The obturator was received.The circular seal was intact.The envelope seal was received still sealed, there was no slit present.The cannula was intact.The obturator was inserted into the trocar assembly but could not penetrate the envelope seal due to the seal not being open.The locking tabs on the obturator functioned properly.Subsequently, the complaint data did display an increased trend.A review of the device history record indicates this device lot number was released meeting all quality release specifications at the time of manufacture.Engineering determined that the absence of the slit in the envelope seal is due to a missed operation by the supplier.A manufacturing enhancement has been implemented.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.

• Brand Name: VERSAPORT V2 OPT BLADELESS 12 SHORT
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 5361497
• MDR Text Key: 36067053
• Report Number: 1219930-2016-00035
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K130435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2016

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 Date: 06/30/2020
• Device Model Number: ONB12SHF
• Device Catalogue Number: ONB12SHF
• Device Lot Number: N5F0688X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/25/2015
• Initial Date FDA Received: 01/12/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/10/2016; 04/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1