MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON ARTICULATING DISSECTOR W MONO CAUTERY; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number SILSDISSECT36

Device Problem Difficult to Open or Close (2921)

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

Event Date 01/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter: during a lap chole, where the device opens and closes, it does not line up right.There was a gap.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).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 engineering review, a pmv review of complaint trends, and an evaluation of the returned device.The instrument was evaluated for electrical conductivity; proper conductivity was observed.The rotation knob functioned properly.The jaws were applied to test media and could grasp the media without issue.The handles opened and closed without any hang ups noted.No functional abnormalities were observed.Engineering determined that the slight misalignment of the jaws, which doesn't violate the device specifications, does not hinder the ability of the device to grasp, manipulate or cauterize tissue.Visual and functional testing of the returned sample confirmed the product met quality release specifications that were tested regarding the reported conditions.A review of the device history record indicates this device lot number was released meeting all medtronic quality release specifications at the time of manufacture.Should new information become available, the file will be re-opened.

• Brand Name: ARTICULATING DISSECTOR W MONO CAUTERY
• 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 06473
• MDR Report Key: 5407113
• MDR Text Key: 37738848
• Report Number: 1219930-2016-00083
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• 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

• Date FDA Received: 02/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: SILSDISSECT36
• Device Catalogue Number: SILSDISSECT36
• Device Lot Number: N5J0705X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1