MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON ENDO GIA ADAPTER XL; STAPLE, IMPLANTABLE

Model Number EGIAADAPTXL

Device Problem Unintended Arm Motion (1033)

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

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, the reload began to articulate on its own once loaded onto the adapter.The reload was removed and loaded again and the same event occurred.A new adapter was used and the device proceeded to work properly.This did not result in unintended colostomy, formal laparotomy, re-operation, etc.There was no unanticipated tissue loss.The incision was not extended by more than one inch.There was no unanticipated blood loss of 500cc or more.Surgery time was not delayed by more than 30 minutes.No device fragment fell into the patient.

Manufacturer Narrative

(b)(4).Post market vigilance (pmv) led an evaluation one adapter.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.Microscopic evaluation revealed 3 cracked solder joints.During functional testing, the reload was unable to be recognized by the software.The adapter was disassembled and positive contact was made with the switch.The reload detect led did not illuminate.The reported condition of uncontrolled articulation was not confirmed and a secondary condition of reload not recognized was determined during the investigation.A review of the device history record indicates this device lot number was released meeting all medtronic quality release specifications at the time of manufacture.A malfunctioning switch is the result of compromised solder joints.The root cause of the observed condition was determined to be a result of a manufacturing activity and a process enhancement has been implemented to prevent this condition from recurring.

• Brand Name: ENDO GIA ADAPTER XL
• 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: 5701766
• MDR Text Key: 46642211
• Report Number: 1219930-2016-00595
• 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: 05/16/2016

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: EGIAADAPTXL
• Device Catalogue Number: EGIAADAPTXL
• Device Lot Number: N6B0637LX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/16/2016
• Initial Date FDA Received: 06/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1