AD-TECH Spencer Probe Depth Electrode Product Usage: The Ad-Tech Depth Electrodes (Depth Electrodes…

Date

Sept. 4, 2019

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

Ad-Tech Medical Instrument Corporation

Product

AD-TECH Spencer Probe Depth Electrode Product Usage: The Ad-Tech Depth Electrodes (Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes) are intended for temporary (< 30 days) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping.

Reason

An Ad-Tech Clinical Specialist, attended a case on April 15, 2019. During the case the surgeon encountered an issue after implanting four Ad-Tech depth electrodes. Upon initial device testing subsequent to implantation it was identified that two of the devices that were labeled as 8 contact depth electrodes (SD08R-SP05X-000) were in fact 6 contact depth electrodes (SD06R-SP05X-000) . There was no impact to the patient due to this incident.

Distribution pattern

Worldwide - Nationwide distribution in the state of Illinois and countries of Russia and United Kingdom

Quantity

18

Codes and lots

Catalog Numbers SD08R-SP05X-000 SD06R-SP05X-000 LOT NUMBERS 127219 208140699 127357 208140699

Recall started

April 16, 2019

Device type

Electrode, Depth

Root cause (FDA)

Labeling Change Control

What the company told customers

Via a MEDICAL DEVICVE RECALL letter dated, April 17, 2019, Ad-Tech advised their consignees of the mix-up, requested that they check their stock, returned the MEDICAL DEVICE RECALL RETURN RESPONSE, and return the subject devices. Distributors were requested to conduct a sub-recall to their customers.

Recall number

Z-2396-2019

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-2396-2019. The agency record governs; check it and the company before acting.