MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC ENDO DISSECT* 5MM INSTRUMENT; MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED

Model Number 176645

Device Problem Failure to Align (2522)

Patient Problems Tissue Damage (2104); No Code Available (3191)

Event Date 01/28/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, while using the instrument the endo dissect approximation of both jaws is not in alignment due to which dissection was found difficult during laparoscopic whipples procedure.There was patient involvement and no patient injury reported.The condition of patient is also fine.There was tissue damage to the mucosa and submucosa tissue layer.This was corrected through suture.Hospital stay was extended for a day.

Manufacturer Narrative

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 jaws were misaligned.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.A review of the device history record indicates this device lot number was released meeting all quality release specifications at the time of manufacture.Subsequently, the complaint data did not display an increased trend.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.

• Type of Device: MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED
• Manufacturer (Section D): COVIDIEN, FORMERLY USSC PUERTO RICO INC; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer (Section G): COVIDIEN, FORMERLY USSC PUERTO RICO INC; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 5454808
• MDR Text Key: 38823234
• Report Number: 2647580-2016-00081
• Device Sequence Number: 1
• Product Code: GET
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K904578
• 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: 02/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: 176645
• Device Catalogue Number: 176645
• Device Lot Number: P4J0775X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2016
• Initial Date FDA Received: 02/23/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/23/2016; 05/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention