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 Not Applicable (3189)

Event Date 12/01/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, during a demonstration, when the reload is attached, it will articulate on its own, and the jaws will open on their own.When the reload moves back to neutral position, it is no longer recognized.

Manufacturer Narrative

Post market vigilance (pmv) led an evaluation of one device.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 by both pmv and engineering.The i investigation was able to replicate the reported conditions.Further investigation found cracked solder joints between the reload detect switch and the mma board.This can lead to intermittent occurrences of the reload not recognized and uncontrolled articulation conditions.Intermittent reload recognition due to 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 good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: 5319901
• MDR Text Key: 34882502
• Report Number: 1219930-2015-01087
• 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: 12/01/2015

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?: Yes
• Device Operator: Other
• Device Model Number: EGIAADAPTXL
• Device Catalogue Number: EGIAADAPTXL
• Device Lot Number: N5K0062LX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/01/2015
• Initial Date FDA Received: 12/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2015
• 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