inforMED
MalfunctionGXZ

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 Europe

Model number

TE/S50715-001

Catalog 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