MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON IDRIVE ULTRA POWERED HANDLE 1; STAPLE, IMPLANTABLE

Model Number IDRVULTRA1

Device Problems Unintended Arm Motion (1033); Entrapment of Device (1212); Failure to Fire (2610)

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

Event Date 12/22/2016

Event Type  malfunction  

Manufacturer Narrative

Ftr# (b)(4).Since the lot number was not provided, this information cannot be determined.

Event Description

According to the reporter, during a laparoscopic assisted distal gastrectomy procedure, on the second firing for the stomach, the surgeon pushed the green firing mode button, but the device did not fire.Then the surgeon tried to release the tissue from the cartridge, but the jaws suddenly articulated.The surgeon was able to release it from the tissue eventually, without damaging it.The nurse then tried to remove the cartridge from the adapter, but was not able to.The cartridge was connected to the adapter and the blue button was pressed and the device did not react but the jaws articulated on its own.The current patient status is okay.

Manufacturer Narrative

(b)(4).Post market vigilance (pmv) led an evaluation of one device.Visual and functional evaluation of the handle noted no abnormalities.Visual and functional testing of the returned product confirmed the product, as received, met release specifications.Product analysis suggests the product was used in a surgical procedure.No enhancements or improvements were generated for the reported condition.The product analysis concluded there were no device abnormalities that would have caused or contributed to the reported incident.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.

• Brand Name: IDRIVE ULTRA POWERED HANDLE 1
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6267610
• MDR Text Key: 65458796
• Report Number: 1219930-2017-00086
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K121510
• 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
• Report Date: 12/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IDRVULTRA1
• Device Catalogue Number: IDRVULTRA1
• Device Lot Number: N6B0485LX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ADAPTER, BATTERY, RELOAD
• Patient Age: 73 YR