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

Model Number IDRVULTRA1

Device Problem Unintended Head Motion (1284)

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

Event Date 03/07/2016

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 colectomy, the device began to rotate on its own inside of the patient cavity.Subsequently, the status indicator turned blue.There was a delay over 30 minutes.A manual device was used to complete the case.There was no injury or adverse event reported.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).Post market vigilance (pmv) concurrently with engineering led an evaluation of one powered handle and one adapter.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, an engineering evaluation of the returned products, and an evaluation of the returned devices.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 adapter was inserted onto the handle and calibrated without issue.The test 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 test reload was again rotated several times, however this time in smaller increments.The handle was disassembled for internal evaluation.The solder connections between the drive motor and bldc board were examined, and were all fully intact, and the motor wires were not kinked.The bldc board was examined, and there were no workmanship issues with the soldering.The reported condition was not confirmed.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.

• 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 mu ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 5531665
• MDR Text Key: 41423981
• Report Number: 1219930-2016-00273
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884521142794
• UDI-Public: 10884521142794
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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,Followup
• Report Date: 03/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2016
• 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: N5L0185LX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2015
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1