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 04/20/2016

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 a sleeve gastrectomy, the adapter would not recognize the reload and the indicator light would not illuminate green.The device was reassembled several times, and the worked properly.Upon reloading the original reload, the reload was recognized, but after insertion and opening, the cartridge articulated on its own.The reload was brought back to neutral and at that point the green reload light went out and handle would not function any more.There was no patient injury or tissue damage.There was no additional blood loss and the procedure was not extended by more than 30 minutes and there was no extension of incision.No buttress material was used.Nothing fell into the patient.The outcome of the patient was fine.

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) led an evaluation of one adapter 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.Microscopic evaluation of the adapter revealed 4 cracked solder joints.The eeprom (electrically erasable programmable read only memory) was uploaded and indicated five (5) autoclave cycles for the adapter.Before a battery was inserted, 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, handle, and reload were not returned, pmv representative devices were utilized for all functional testing.After a pmv battery was inserted, the adapter was inserted onto a pmv handle and calibrated without issue.All five white status lights illuminated indicating more than 15 surgeries remaining on the adapter.A pmv reload was inserted onto the adapter and the reload detect led did not illuminate, indicating that the software did not recognize the presence of a reload.The unload button on the adapter was depressed numerous times and displayed no hang-ups or sluggish returns.A pmv reload was inserted onto the adapter again, and the reload detect led did not illuminate, indicating that the software did not recognize the presence of a reload.The adapter was disassembled and positive contact was made with the switch.The reload detect led illuminated intermittently.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 will be 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 ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 5651624
• MDR Text Key: 45095390
• Report Number: 1219930-2016-00433
• 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,Followup
• Report Date: 04/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EGIAADAPTXL
• Device Catalogue Number: EGIAADAPTXL
• Device Lot Number: N5L0379LX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/20/2016
• Initial Date FDA Received: 05/12/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/15/2016; 08/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2015
• 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