TECHNOMED EUROPE
Received Dec 10, 2021 · Event occurred Nov 30, 2021
Report 9710376-2021-00003 · MDR key 12974279
Device
Generic name
Disposable Subdermal Needle Electrode, Corkscrew
Manufacturer
Technomed EuropeModel number
TE/S50715-001Catalog number
TE/S50715-001
Lot number
049989 OR 049528
Product problems
- Material Separation
- Material Separation
Patient
56 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE PROBLEM OCCURRED WITH THE SECOND CORKSCREW THEY USED DURING THE PROCEDURE, THE FIRST ONE WENT FINE. THE USER INSERTED IT A HALF TURN, BUT IT COULD NOT BE INSERTED COMPLETELY INTO THE SKIN AS THE HUB STARTED TURNING. SHE HAD NO GRIP ON THE NEEDLE ANYMORE. THEN, SHE TRIED TO PULL IT OUT, BUT THE NEEDLE DID NOT COME OUT DUE TO LACK OF GRIP BECAUSE OF THE LOOSE HUB. THE SURGEON WAS IN A HURRY, WHICH IS WHY THEY PLACED A NEW CORKSCREW AND LEFT THE DEFECTIVE ONE AS IS. AFTER THE SURGERY, THE SURGEON USED A LITTLE SURGICAL INSTRUMENT (FORCEPS) TO REMOVE THE NEEDLE. 1MM AT A TIME, HE PULLED IT OUT. THE PATIENT BLED QUITE A LOT AFTER THE NEEDLE CAME OUT. THE NEEDLE WAS STILL ATTACHED TO THE LEAD WIRE. DUE TO USING PRESSURE, THE NEEDLE WAS DEFORMED. THE WOUND WAS STAUNCHED AND BLEEDING STOPPED AFTER A WHILE. NO STITCHING WAS NECESSARY.
Remedial action
- Replace
- Recall