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); Device Displays Incorrect Message (2591)

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

Event Date 03/10/2016

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, the reload articulated on its own.It stopped and the status indicator light illuminated blue.The reload was unable to be straightened.A new handle and reload were used to finish the procedure.There was no injury or adverse event reported.

Manufacturer Narrative

(b)(4).Device egia60avm 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) led an evaluation of one reload opened by the account.Visual examination of the staple cartridge noted that the reload had a full staple complement.The reload was loaded into a pmv representative instrument for functional testing.The reload detect led started flashing as intended, indicating that the software recognized the presence of a reload.The reload loaded, unloaded, rotated, articulated, and opened and closed properly without difficulty.The reload was applied to test media.All staples were placed and the test media was cleanly transected.Functional testing confirmed the safety interlock feature successfully prevented the reload from cycling again.A review of the device history record indicates this 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 amended as appropriate.

Manufacturer Narrative

Evaluation summary: additional device investigation due to additional product received: post market vigilance (pmv) led an evaluation of one powered handle and one adapter opened by the account.This evaluation was based on a technical review of all data received from the site, a pmv review of complaint trends, engineering review of the product and an evaluation of the returned device.Visual inspection of the handle and adapter noted no abnormalities.Functional evaluation of the adapter noted no abnormalities and the reported conditions were not replicated.Functional evaluation of the handle noted that there was a severed wire on the bldc board.Potential root cause for a severed wire is an error during the wire stripping operation.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 mu ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 5532767
• MDR Text Key: 41417022
• Report Number: 1219930-2016-00283
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K121510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/10/2016

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: N6B0149LX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/10/2016
• Initial Date FDA Received: 03/29/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 04/19/2016; 05/09/2016; 12/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1