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

Model Number EGIAADAPT

Device Problems Unintended Arm Motion (1033); Difficult to Remove (1528); Device Displays Incorrect Message (2591)

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

Event Date 05/18/2016

Event Type  Death  

Manufacturer Narrative

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

Event Description

According to the reporter, during a sleeve gastrectomy, when the reload was loaded, the device did not recognize the reload and had no display indicator light flashing above the reload indicator.The reload was unloaded and loaded again with no recognition afterwards.The device was then fully disassembled and reassembled.The device then recognized the reload.The device was fired and the a second reload was loaded and recognized.The reload was placed through the trocar and then began to articulate on its own.At this point, the device then froze and became unresponsive to any buttons or toggles being pushed.The surgeon slid the trocar sleeve up the device and removed the stapler with reload still attached from the incision site.A different adapter was used and no issues occurred, the same reload was recognized and fired successfully.This problem 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.The patient is in good condition.

Manufacturer Narrative

(b)(4).Post market vigilance (pmv) led an evaluation of 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, engineering review of the product and an evaluation of the returned device.Visual evaluation noted cracked solder joints during microscopic evaluation.A functional evaluation replicated the reported condition and found one cracked solder joint and a bowed switch.The root cause of this condition is an improper assembly or solder of the switch to the board.A manufacturing action has been implemented to prevent recurrence of this condition.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 STANDARD
• 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: 5708509
• MDR Text Key: 46870238
• Report Number: 1219930-2016-00608
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/18/2016

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: EGIAADAPT
• Device Catalogue Number: EGIAADAPT
• Device Lot Number: N6B0814LX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/18/2016
• Initial Date FDA Received: 06/09/2016
• 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: Unknown
• Patient Sequence Number: 1