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

Model Number EGIAADAPT

Device Problem Unintended Arm Motion (1033)

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

Event Date 12/15/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, during a sleeve gastrectomy, the reload articulated on its own after device assembly.Subsequently, when the adapter was placed on different handles, solid blue lights were displayed.There was no injury or adverse event reported.

Manufacturer Narrative

(b)(4).Post market vigilance (pmv) led an evaluation of one adapter opened by the account.No visual abnormalities were noted for the adapter.The eeprom (electrically erasable programmable read only memory) was uploaded and indicated 23 autoclave cycles for the adapter.Functionally, 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 and 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 ones were utilized for all functional testing.The adapter was inserted onto the handle and calibrated without issue.All five white status lights illuminated indicating more than 15 surgeries remaining on the adapter.A reload was inserted onto the adapter and the reload detect led started flashing as intended, indicating that the software recognized the presence of a reload.The reload was closed and then opened to change the flashing green reload detect led to a solid green state.The adapter was rotated clockwise in increments of forty-five degrees and fully articulated left and right each time to detect an out of round sulu load ring but the reload detect led did not turn off indicating that the software recognized the presence of a reload the entire time.The pmv reload was then cycled without hesitation or binding.A review of the adapter device history record indicates the device lot number was released meeting all medtronic quality release specifications at the time of manufacture.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: 5369902
• MDR Text Key: 36472487
• Report Number: 1219930-2016-00022
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2015

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 Model Number: EGIAADAPT
• Device Catalogue Number: EGIAADAPT
• Device Lot Number: N5H0912LX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2015
• Initial Date FDA Received: 01/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2015
• 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