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 Problems Material Separation (1562); Detachment of Device or Device Component (2907)

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

Event Date 08/28/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional attempts to obtain information and the device have been made.A supplemental report will be submitted with new details if they become available.(b)(4).

Event Description

According to the reporter, the inner shaft was peeled off by itself.Only rotating once.Patient is not involved.

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, a pmv review of complaint trends, and an evaluation of the returned device.The sheath of the inner shaft was noted to be peeling.Functional evaluation notes that the rotation knob functions properly.The graspers were applied to test media and grasped the media without issue.The handles opened and closed without any hang ups noted.The jaws could extend without issue.No functional abnormalities were observed.A review of the device history record indicates this device lot number was released meeting all quality release specifications at the time of manufacture.There were no adverse patient events reported as a result of the alleged event.Should new information become available, the file will be re-opened and reassessed at that time.

Event Description

Procedure: lap.Hysterectomy.

• 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: 5091375
• MDR Text Key: 26441822
• Report Number: 2647580-2015-00666
• Device Sequence Number: 1
• Product Code: GET
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K914753
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Followup,Followup
• Report Date: 10/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: 174233
• Device Catalogue Number: 174233
• Device Lot Number: P4J0337X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1