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 10/27/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, during a lap assisted distal gastrectomy, the device was set up and the reload was attached.The reload symbol was flashing.The open/close check of the jaws was done, however the reload symbol kept flashing.The reload was disconnected and reattached, but the reload symbol was still flashing.The device was reassembled completely, then the reload symbol illuminated green.The surgeon inserted the device through the trocar and attempted to approach to the tissue.However, reload started to move by itself in the cavity.The surgeon tried to remove the device through the trocar; however, the articulated jaws could not be straightened.The device was removed along with the trocar.New devices were used to correct the problem.When our sales rep received the device in question along with the trocar, the blue light was illuminated and the reload symbol was flashing.

Manufacturer Narrative

(b)(4).Post market vigilance (pmv) led an evaluation of one adapter standard.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 device by both pmv and engineering.The investigation was able to replicate the reported conditions of uncontrolled articulation, received light sequence to replace reload, and solid blue lights.The condition of difficult to straighten was not able to be replicated.The conditions of received light sequence to replace reload and solid blue lights were found to be symptoms of the uncontrolled articulation condition.Investigation the revealed the mma board itself was bowed downward in the location of the switch.The deformation of the mma switch causes the switch to sit lower relative to the leaf spring, requiring additional travel of the leaf spring to activate.The loss of activation height following manufacturing caused the device to lose reload recognition in select orientations, causing the device to recalibrate and result in an "uncontrolled articulation" condition.Should new information become available, the file will be re-opened and the investigation summary 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 ; 2034925267
• MDR Report Key: 5240098
• MDR Text Key: 32031236
• Report Number: 1219930-2015-01016
• 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
• Report Date: 10/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IDRVULTRA1
• Device Catalogue Number: IDRVULTRA1
• Device Lot Number: N5B0047LX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2015
• Initial Date FDA Received: 11/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/25/2016
• 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