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 11/30/2015

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 laparoscopic right hemicolectomy, after the reload was attached to the handle, the device began to articulate on its own.The device was not used on a patient.A new device was used to complete the procedure.There was no injury or adverse event associated with this incident.Additional information has been requested but not yet received.A supplemental report will be submitted upon receipt of any new information.

Manufacturer Narrative

Tracking number: (b)(4).This report is based on information provided by an engineering evaluation.Received one adapter standard opened by the account without the display box or any packaging.A visual inspection found that there were no visual abnormalities were noted for the adapter.The reported condition of uncontrolled articulation was unable to be replicated and the reported condition of reload not recognized was confirmed.The investigation isolated the failure to cracked solder joints between the reload detect switch and the mma board.A malfunctioning switch is the result of several variables including: improper solder operation at the vendor location, improper assembly of the sealed switch to the mma board at the vendor location, and/or improper soldering during assembly.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 ; north haven, CT 06473 ; 2034925267
• MDR Report Key: 5325034
• MDR Text Key: 34920376
• Report Number: 1219930-2015-01091
• 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: 12/03/2015

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?: No
• Device Operator: Health Professional
• Device Model Number: IDRVULTRA1
• Device Catalogue Number: IDRVULTRA1
• Device Lot Number: N4K0668LX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2015
• Initial Date FDA Received: 12/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• 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