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 11/12/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, during a sleeve gastrectomy, the handle would not power the load closed.The system was disassembled and reassembled twice and the issue persisted.A new battery was placed in the handle.It worked for one fire.As the surgeon was moving the used reload away from the staple line, the reload began to articulate left and right.A new stapler was used and worked fine and without issue.No patient injury or adverse event was reported.

Manufacturer Narrative

Tracking number: (b)(4).Device has been received but evaluation not yet begun.A supplemental report will be sent upon completion of investigation.

Manufacturer Narrative

Tracking number: (b)(4).This report is based on information provided by an engineering evaluation.One adapter was received for evaluation.A visual inspection found no notable conditions.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.A review of the device history records indicates the device lot numbers were released meeting all medtronic quality release specifications at the time of manufacture.

Manufacturer Narrative

Due to review of the file based on a request for additional information, it was determined that the incorrect incident description was provided in the initial report of this event.Per the initial reporter, the incorrect incident was reported in error.The correct report has been provided on this supplemental report.This file has been updated to reflect the correct incident description.

Event Description

According to the reporter, the device did not work for the surgeon.The case began with all of the green lights correctly lit and blinking when appropriate.The scrub tech loaded the first reload and the device fired correctly.The surgeon took the device out of the patient and the scrub tech went to cycle the device (open and close the jaws) the trigger wouldn't power the jaws to close and the reload was stuck in position.I instructed the scrub tech to take the battery out of the back and reinsert the battery to reset the device.The scrub tech did so and the lights went to the appropriate colors and the jaws again would not close.The 2nd time the scrub tech reset the device, it worked correctly.The scrub tech was able to take the used reload off of the adapter and replace it with a new reload.The surgeon went to fire the 2nd reload and the reload would not open to go around the tissue.The surgeon took the reload out of the patient.At this point we felt it necessary to no longer use that device and to get a new one.We did so and the new device worked fine for the rest of the case.Current patient status: the patient is fine, the is no harm to the patient.

Manufacturer Narrative

(b)(4).This report is based on information provided by an engineering evaluation.One adapter was received for evaluation.An initial visual inspection found no notable conditions.The reported condition of inability to close the jaws was confirmed.The reported condition of inability to open the jaws was not confirmed.There were no abnormalities noted that would have caused or contributed to the reported inability to open the jaws.The returned sample did not meet specification.The investigation isolated the failure to cracked solder joints between the reload detect switch and the mma board.This condition has been addressed in current production through enhancements in the assembly process.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 file will be closed as an assembly error relative to inability to close the jaws.Should new information become available, the file will be re-opened and reassessed at that time.

• 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: 5268129
• MDR Text Key: 32950368
• Report Number: 1219930-2015-01052
• 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: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/14/2016

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?: Yes
• Device Operator: Health Professional
• Device Model Number: IDRVULTRA1
• Device Catalogue Number: IDRVULTRA1
• Device Lot Number: N5D0604LX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2015
• Initial Date FDA Received: 12/04/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/14/2016; 08/18/2016; 09/15/2016; 11/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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