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 Break (1069); Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, prior to a lap nissen procedure, the staff noticed a piece of material sticking out shaft, just proximal to the jaws of the instrument.Device in question will be sent in for review.The operator did continue to use the device, without issues.They used the device throughout the case with no issue, however thought it best to report the protruding material.To correct the condition, the staff used the endo grasp without issue.

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 reported condition for this incident was that the sheath was damaged.The tube sheath was damaged posterior to the jaws.The rotation knob functioned without difficulty.The jaws extended and retracted without difficulty.The jaws opened and closed without difficulty.Visual and functional testing of the returned product confirmed the product did not meet quality release specifications that were tested regarding the reported conditions due to the damaged sheath.Replication of damaged sheath condition may occur due to extreme handling during the application.Based on the product analysis, the failure was confirmed to be attributed to the reported event.A review of the current historical complaint data reveals no trend for a device related failure for this condition.The file will be closed as a misuse of the product.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: 5706084
• MDR Text Key: 46797959
• Report Number: 2647580-2016-00303
• Device Sequence Number: 1
• Product Code: GET
• UDI-Device Identifier: 10884523000818
• UDI-Public: (01)10884523000818(17)191031(10)P4K0370X
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K914753
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: 174233
• Device Catalogue Number: 174233
• Device Lot Number: P4K0370X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• 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 Age: 68 YR