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 Date 10/15/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, during a sleeve gastrectomy, after the reload was inserted into the abdominal cavity, the reload began to move on its own to the left and right.The blue lights were illuminated.There was no extension of surgery more than 30 minutes.There was no blood loss over 500 cc's.There was no extension of the incision more than one inch.There was no unanticipated tissue loss or tissue damage.No portion of the device fell into the cavity.No reinforcement material was used.

Manufacturer Narrative

(b)(4).The concomitant device is egia60amt and the lot number is unknown.

Manufacturer Narrative

(b)(4).Summary: post market vigilance (pmv) led an evaluation of one endo gia adapter xl, several staples, and one endo gia* 60mm articulating medium/thick reload opened by the account.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.The reported condition for this incident was that during a sleeve gastrectomy procedure, the adapter uncontrollably articulated.The staples were overcrimped.Visual examination of the staple cartridge noted that the reload was fully fired.One lug at the proximal end of the adapter was fractured and received separated from the reload.The articulation flag was bent.No visual abnormalities were noted for the adapter.The eeprom was uploaded and indicated 50 autoclave cycles for the adapter.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.Since the clinical battery and handle were not returned, pmv representative ones were utilized for all functional testing.A pmv idrive battery pack was loaded into the pmv representative idrive ultra.The idrive ultra powered up properly.The adapter was inserted onto the handle displayed one blinking green light above the adapter symbol, five blinking white firing progress indicator lights, and solid blue status indicator lights, indicating that the adapter had reached end of life.The subject reload was loaded onto the handle.The device could not be fired due to the adapter reaching end of life.It was noted that when the reload was articulated fully to the left of neutral position and returned to neutral position by pressing the blue and silver buttons simultaneously, the reload began to articulate on its own.The reload was then attached to a pmv representative idrive adapter and idrive ultra handle and this same articulation condition was replicated.The subject adapter was again loaded onto a pmv representative handle.Again, the handle displayed one blinking green light above the adapter symbol, five blinking white firing progress indicator lights, and solid blue status indicator lights, indicating that the adapter had reached end of life.

Event Description

A pmv representative reload was attached and the device was able to close and open the reload jaws, articulate, and rotate as expected.The device could not be fired due to the handle reaching end of life.Visual and functional testing of the returned sample confirmed the product did not meet quality release specifications that were tested regarding the reported conditions due to the damaged sulu lug.The reported condition was confirmed.A review of the adapter device history record indicates this device lot number was released meeting all medtronic quality release specifications at the time of manufacture.The correct handle lot number was not received verify the expiration date of the reload.Subsequently, the complaint data did not display an increased trend.Replication of the broken sulu lug condition can occur if the reload is over torqued during unloading and / or if an attempt is made to unload the reload without using the release button.If the sulu lug is broken, proper connection with the adapter may be lost, resulting in articulation of the reload as the adapter attempts to recalibrate.The adapter displayed blue lights but this was due to the device reaching end of life.Based on the trend, no product enhancement will be generated.The file will be closed as a misuse of the product.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.

• 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 ; 2034925267
• MDR Report Key: 5223391
• MDR Text Key: 31366762
• Report Number: 1219930-2015-00999
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K121510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/23/2015

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: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: EGIAADAPTXL
• Device Catalogue Number: EGIAADAPTXL
• Device Lot Number: N4E0608UX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/23/2015
• Initial Date FDA Received: 11/13/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/03/2015; 12/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• 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