MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC ROTICULATOR ENDO GRASP* 5MM W/SPIN LOCK; MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED

Model Number 174233

Device Problem Failure to Align (2522)

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

Event Date 11/18/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, during a thoraco/wedge/segmental resection, a new sulu was opening, the jaws had been misaligned badly and did not engage properly.Stopped using the device and new one was opened to correct the problem.No patient involved.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Post market vigilance (pmv) led an evaluation received 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, a pmv review of complaint trends, and an evaluation of the returned device.Engineering noted that the clevis curvature was observed bent or forced.This condition is not related to manufacturing process.A review of the device history record indicates this device lot number was released meeting all quality release specifications at the time of manufacture.Replication of damaged sheath condition may occur due to extreme handling during the application.The clevis curvature was observed bent or forced.Typically, this type of condition is observed in this unit when an excessive force or leverage is performed on the device during usage.As results of the excessive force the jaws will lose the force to open.It is possible to observe the jaws closed; however the jaws will be loose and will not remain closed with force.Should new information become available, the file will be re-opened and the investigation summary 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: 5250031
• MDR Text Key: 32284644
• Report Number: 2647580-2015-00831
• Device Sequence Number: 1
• Product Code: GET
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K914753
• 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: 12/09/2015

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: 174233
• Device Catalogue Number: 174233
• Device Lot Number: P5F0138X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2015
• Initial Date FDA Received: 11/25/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/30/2015; 06/15/2016
• 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