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 04/26/2011

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device has not been received.A supplemental report will be sent upon completion of investigation if device is received.

Event Description

According to the reporter, during a sleeve gastrectomy, the handle, adapter, and reload were assembled.When the tech attempted to cycle the device, the reload started articulating and then remained in the articulated position.The adaptor was removed and replaced back onto the handle.Then the reload was able to be removed.A new adaptor was tried on the handle but the same incident occurred.A new handle was used and then the device operated properly.It is unknown if reinforcement material was used.There was no injury, delay or adverse event reported.

Manufacturer Narrative

Tracking number: (b)(4).Device has been received but evaluation not yet begun.A supplemental report will be sent upon completion of investigation.Correction to previously submitted reports regarding a manually created gap in the sequence number of follow up supplemental reports.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Tracking number: (b)(4).Device has been received but evaluation not yet begun.A supplemental report will be sent upon completion of investigation.

Manufacturer Narrative

Tracking number: (b)(4).Post market vigilance (pmv) led an evaluation of one powered handle 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 devices.The eeprom (electrically erasable programmable read only memory) was uploaded and indicated 19 autoclave cycles for the handle.The quick connect was functionally 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.Since the clinical battery, adapter, 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.A pmv adapter was inserted onto the handle and calibrated without issue.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 handle device history record indicates the 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: 5664923
• MDR Text Key: 45475343
• Report Number: 1219930-2016-00500
• 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,Followup,Followup
• Report Date: 12/16/2019

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: N5B0742LX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/26/2016
• Initial Date FDA Received: 05/18/2016
• Supplement Dates Manufacturer Received: 11/25/2019; 11/25/2019; 11/25/2019
• Supplement Dates FDA Received: 12/16/2019; 06/15/2016; 08/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2015
• 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