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

Model Number IDRVULTRA1

Device Problems Unintended Head Motion (1284); Device Difficult to Setup or Prepare (1487)

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

Event Date 12/07/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information has been requested but not yet received.A supplemental report will be submitted upon receipt of any new information.(b)(4).

Event Description

According to the reporter, during a roux-en-y, the adapter proved difficult to load onto the handle.The adapter arm also rotated on its own when clamped down on tissue.A manual handle was used to finish case without any complications.No injury or adverse event was reported.Additional information has been requested but not yet received.A supplemental report will be submitted upon receipt of any new information.

Manufacturer Narrative

(b)(4).Post market vigilance (pmv) led an evaluation of one idrive ultra powered handle 1 and one endo gia 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 reported condition for this incident was uncontrolled rotation and difficult to attach idrive adapter during a roux-en-y procedure.A review of the device history records indicates the device lot numbers were released meeting all quality release specifications at the time of manufacture.The investigation was able to replicate the reported condition of difficult to attach idrive adapter.Visual examination showed damage to the quick connect which can impede connection of the adapter to the handle.While the condition of uncontrolled rotation could not be replicated, visual examination showed excessive mismatch on the front handle which can lead to fluid ingress into the handle.Also, inconsistencies in the bldc board coating were noted, which makes the board susceptible to the effects of moisture and can lead to intermittent failure as described by the account.A product improvement has been implemented to prevent this failure from reoccurring.Difficulty attaching the idrive adapter can be caused by damage to the quick connect due to rough handling of the device.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 ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 5325350
• MDR Text Key: 34920667
• Report Number: 1219930-2015-01093
• 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
• Report Date: 12/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IDRVULTRA1
• Device Catalogue Number: IDRVULTRA1
• Device Lot Number: N5D0921LX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/19/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2015
• 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