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

Model Number IDRVULTRA1

Device Problem Unintended Arm Motion (1033)

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

Event Date 12/14/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, during a partial gastrectomy, the jaws of the reload articulated on their own when attached to the handle.The reload was detached from the adapter, but could not be reconnected.A manual handle was used to complete the case.There was no injury or adverse event reported.

Manufacturer Narrative

(b)(4).Post market vigilance (pmv) led an evaluation of one adapter and one reload opened by the account.Visual inspection of the cartridge revealed that the reload had a full staple complement.The unload button on the adapter was fully depressed.No additional visual abnormalities were noted for the adapter.The eeprom (electrically erasable programmable read only memory) was uploaded and indicated 8 autoclave cycles for the adapter.Functionally, the isi pin location of the adapter was checked and found to be at the center.The center rod orientation of the adapter was checked and was found to be assembled properly.The unload button on the adapter was depressed and was unable to be pushed back to the resting position.The adapter was disassembled and extensive damage was seen on the lockout slider block, the non-welded tip housing, and the cam block.The adapter was then reassembled.The isi pin location of the adapter was checked and found to be at the center.The center rod orientation of the adapter was checked and was found to be assembled properly.The unload button on the adapter was depressed and was unable to be pushed back to the resting position.The adapter was disassembled and extensive damage was seen on the lockout slider block, the non-welded tip housing, and the cam block.The adapter was then reassembled.Since the clinical battery and handle were not returned, pmv representative ones were utilized for all functional testing.A pmv pack was loaded into a handle.The adapter was inserted onto the handle and powered up and calibrated as expected.All five white status lights illuminated indicating more than 15 surgeries remaining on the adapter.The subject reload was inserted onto the adapter and the reload detect led started flashing as intended, indicating that the software recognized the presence of a reload.The reload was closed and then opened to change the flashing green reload detect led to a solid green state.The adapter was rotated clockwise in increments of forty-five degrees and fully articulated left and right each time to detect an out of round sulu load ring but the reload detect led did not turn off indicating that the software recognized the presence of a reload the entire time.The pmv reload was applied to test media with proper transection and stapling.A review of the device history records indicates the device lot numbers were released meeting all medtronic quality release specifications at the time of manufacture.Replication of the damage seen on the lockout slider block is consistent with a user attempting to fire a sulu when one is not fully attached.When the block becomes jammed it can prevent the lockout cam block and sulu load link from returning to its resting state.The sulu load link connects to the "unload" button, in turn causing that to become stuck in place.No enhancements or improvements were generated.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: 5358079
• MDR Text Key: 35982181
• Report Number: 1219930-2016-00030
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IDRVULTRA1
• Device Catalogue Number: IDRVULTRA1
• Device Lot Number: N5C0645LX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2015
• Initial Date FDA Received: 01/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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