According to the reporter, during a laparoscopic assisted distal gastrectomy.When sulu was attached to the adapter, it was not recognized.The release button was pushed up and down, and the reload was eventually recognized.When the surgeon attempted to fire the device, the jaws abruptly started to move side to side by themselves.A new device was used to complete the case.It is unknown if reinforcement material was used.There was no injury, adverse event or delay reported.
|
(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.No visual abnormalities were noted for the adapter.The eeprom (electrically erasable programmable read only memory) was uploaded and indicated thirty-four (34) 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 devices 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 pmv reload was inserted onto the adapter and the reload detect led started flashing, 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 adapter was disassembled and positive contact was made with the switch.The reload detect led illuminated.A review of the device history record indicates this 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.
|