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

Model Number 176645

Device Problems Mechanical Problem (1384); Failure to Align (2522)

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

Event Date 07/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, during a laparoscopic cholecystectomy, the alignments of the jaws were out of the position and it could not grip properly.There was no patient involvement.Another device was used.No known adverse events were reported.

Manufacturer Narrative

(b)(4).Post market vigilance (pmv) and engineering led an evaluation of two endo dissect devices.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, an engineering evaluation, and an evaluation of the returned device.The visual inspection of each device noted some misalignment of the jaws, however upon evaluation the device was found to be within specifications.The instrument was evaluated for electrical conductivity; proper conductivity was observed both in normal position and in roticulated position.The rotation knob functioned properly, and the jaws opened and closed grasping test media without difficulty.Visual and functional testing of the returned product confirmed the product met all functional test specifications.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: matthew amaral ; 60 middletown ave; north haven, CT 06473 ; 2034926373
• MDR Report Key: 5842852
• MDR Text Key: 51017375
• Report Number: 2647580-2016-00549
• Device Sequence Number: 1
• Product Code: GET
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K904578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: 176645
• Device Catalogue Number: 176645
• Device Lot Number: P6A0125X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2016
• 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