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 01/14/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device has not been returned.Should the device be returned, a supplemental report will be filed.

Event Description

According to the reporter, during a laparoscopic sigmoidectomy, the device was assembled and put on the instrument table.However, the jaws of the reload moved on their own, left to right.The system was reassembled and placed on the instrument table again, however, the issue was duplicated.A new system was opened to continue the case.There was no injury or adverse event reported.

• 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: 5427436
• MDR Text Key: 37976766
• Report Number: 1219930-2016-00104
• 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: Other
• Type of Report: Initial
• Report Date: 01/19/2016

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?: No
• Device Operator: Health Professional
• Device Model Number: IDRVULTRA1
• Device Catalogue Number: IDRVULTRA1
• Device Lot Number: N4M1149LX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/19/2016
• Initial Date FDA Received: 02/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• 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