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 02/29/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device has not been received.A supplemental report will be sent upon completion of investigation if device is received.

Event Description

According to the reporter, during the sleeve gastrectomy, the device calibrated inside the abdomen, and the reload moved on its own.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).Post market vigilance (pmv) concurrently with engineering led an evaluation of one powered handle and one adapter.This evaluation was based on technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends, an engineering evaluation of the returned products and an evaluation of the returned devices.No initial visual abnormalities were noted for the handle.The quick connect was functionally depressed numerous times and displayed no hang-ups or abnormalities.The articulation, rotation, close/fire, open and push to fire buttons and knobs were twisted and depressed all showing full functionality.The unload button on the adapter was depressed numerous times and displayed no hang-ups or sluggish returns.The isi pin location was checked and found to be at the center.The center rod orientation was checked and was found to be assembled properly.Microscopic evaluation revealed 2 cracked solder joints around the switch.Testing showed that when probing opposite sides of the switch that the idrive ultra would successfully recognize a reload.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.

Manufacturer Narrative

(b)(4).

• 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: 5520763
• MDR Text Key: 41015586
• Report Number: 1219930-2016-00258
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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,Followup
• Report Date: 03/01/2016

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: N6A0750LX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2016
• Initial Date FDA Received: 03/23/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 04/19/2016; 12/21/2016; 02/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2016
• 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