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 12/22/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, during a laparoscopic total gastrectomy, the jaws of the reload articulated on their own.There was no reaction when the blue and silver buttons were pushed.The jaws eventually could be returned to the straight position, but then the articulation was repeated.The device then lost activation and the status lights illuminated blue.The adapter and battery were removed and replaced, but the status indicator did not change.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).Evaluation summary: post market vigilance (pmv) led an evaluation of one idrive ultra powered handle 1 and one idrive battery pack.The customer did not return the endo gia adapter.Functional testing of the battery showed that the battery would not power up a handle.Visual examination of the idrive handle noted no abnormalities.The internal memory of the idrive handle confirmed it had been processed through seven autoclave cycles.The internal memory also recorded failure of the selector motor to move into position.Functional testing of the idrive handle was performed with a battery pack and reload from our inventory.The reload jaws closed properly, but the idrive failed to open the jaws.The idrive status lights and internal memory also noted this condition.Further visual examination of the idrive handle internal components noted corrosion, damage to the silicon potting around the led board, and the absence of an o-ring.The missing o-ring allowed ingress of moisture during the customer's autoclave process.The reported condition related to the solid blue status lights was confirmed and resulted from corrosion of internal components.The damage to the battery is most likely due to a short circuit condition on the power supply connections due to moisture ingress in the idrive handle.The reported condition of uncontrolled articulation could not be confirmed without the endo gia adapter that was used during this surgical procedure.

• 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: 5371111
• MDR Text Key: 36481211
• Report Number: 1219930-2016-00042
• 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: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2016

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: N4F1433ULX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/24/2015
• Initial Date FDA Received: 01/15/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/05/2016; 09/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• 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