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 12/01/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information has been requested but not yet received.A supplemental report will be submitted upon receipt of any new information.(b)(4).

Event Description

According to the reporter, during a sleeve gastrectomy, the device articulated three separate times without the user touching the buttons.After four firings, it also would not fire the last reload.The device was reassembled but no indicator lights were illuminated.There was no injury or adverse event reported.Additional information has been requested but not yet received.A supplemental report will be submitted upon receipt of any new information.

Manufacturer Narrative

(b)(4).Post market vigilance (pmv) concurrently with engineering led an evaluation of one handle and one adapter opened by the account.No visual abnormalities were noted for the handle or adapter.The eeprom was uploaded and indicated 3 autoclave cycles for the adapter.The eeprom (electrically erasable programmable read only memory) was uploaded and indicated 6 autoclave cycles for the handle.Functionally, the quick connect was depressed numerous times and displayed no hang-ups or abnormalities.The articulation, rotation, close/fire, open and push to fire buttons and knobs were twisted and depressed all showing full functionality.The unload button on the adapter was depressed numerous times and displayed no hang-ups or sluggish returns.The isi pin location was checked and found to be at the center and the center rod orientation was checked and was found to be assembled properly.Since the clinical battery and reload were not returned, pmv representative ones were utilized for all functional testing.A pmv battery pack was loaded into the device.The device powered up properly and system calibration was successful indicated by the steady green light above the handle symbol.All five white status lights illuminated indicating more than 15 surgeries remaining on the handle.The adapter was inserted onto the handle and calibrated without issue.All five white status lights illuminated indicating more than 15 surgeries remaining on the adapter.A pmv reload was inserted onto the adapter and the reload detect led immediately 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 in increments of forty five degrees and fully articulated left and right each time, and the device recognized the reload the entire time.The pmv reload was then cycled without hesitation or binding.A review of the device history records indicates each device lot number was released meeting all medtronic quality release specifications at the time of manufacture.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: 5319618
• MDR Text Key: 34810162
• Report Number: 1219930-2015-01085
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121510
• 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
• Report Date: 12/01/2015

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 Model Number: IDRVULTRA1
• Device Catalogue Number: IDRVULTRA1
• Device Lot Number: N5K0702LX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/01/2015
• Initial Date FDA Received: 12/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2015
• 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