Model Number 5142.6000.000A |
Device Problem
Material Fragmentation (1261)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/17/2022 |
Event Type
malfunction
|
Event Description
|
On (b)(6) 2022, dixi medical usa notified dixi medical of a customer complaint from cleveland clinic (complaint (b)(4)).The complaint is related to the kip-acs-600 dura electrode device (lot number 204244-09/21) with a breakage of its insulating part at the distal end of the product.On (b)(6) 2022, additional information was sent to us concerning the fact that the ceramic piece has penetrated inside the cranial box and a new surgery is required to remove it.This new information led to the decision to report the case.
|
|
Manufacturer Narrative
|
Description of events: on (b)(6) 2022, dixi medical usa notified us of a customer complaint from charles shor center for epilepsy cleveland clinic.The complaint is related to the kip-acs-600 dura electrode device (lot number 204244-09/21) with a breakage of its insulating part (refer to picture in attachment).On (b)(6) 2022 customer complaint (b)(4) was opened at dixi medical.On (b)(6) 2022, request made for additional information.On (b)(6) 2022, reception of the device and start of technical and documentary investigation.On (b)(6) 2022, dixi medical usa informs us that the insulating ceramic part having detached from the device entered the patient's cranium requiring further surgery.This new information was taken into account in the decision to report the case to the fda.At this stage documentation and technical investigation have been done without detecting issues on the device.Further investigation are on-going related to the use of the device.
|
|
Event Description
|
On march 18, 2022, dixi medical usa notified dixi medical of a customer complaint from (b)(6) clinic complaint (b)(4).The complaint is related to the kip-acs-600 dura electrode device (lot number 204244-09/21) with a breakage of its insulating part at the distal end of the product.On may 17, 2022, additional information was sent to us concerning the fact that the ceramic piece has penetrated inside the cranial box and a new surgery is required to remove it.This new information led to the decision to report the case.
|
|
Manufacturer Narrative
|
Description of events: on march 18, 2022, dixi medical usa notified us of a customer complaint from (b)(6) clinic.The complaint is related to the kip-acs-600 dura electrode device (lot number 204244-09/21) with a breakage of its insulating part.On (b)(6) 2022, customer complaint (b)(4) was opened at dixi medical.On april 6 & 20, 2022, request made for additional information on may 5, 2022, reception of the device and start of technical and documentary investigation.On may 17, 2022, dixi medical usa informs us that the insulating ceramic part having detached from the device entered the patient's cranium requiring further surgery.This new information was taken into account in the decision to report the case to the fda.At this stage documentation and technical investigation have been done without detecting issues on the device.Further investigation are on-going related to the use of the device.
|
|
Search Alerts/Recalls
|
|