TECHNOMED EUROPE
Received Nov 15, 2021 · Event occurred Nov 10, 2021
Report 9710376-2021-00002 · MDR key 12811651
Device
Generic name
Disposable Subdermal Needle Electrode, Corkscrew
Manufacturer
Technomed EuropeModel number
TE/S50715-001Catalog number
TE/S50715-001
Lot number
049662
Product problems
- Material Separation
- Material Separation
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CORKSCREW ELECTRODE WAS INSERTED INTO A PATIENT'S SCALP, WAS REMOVED, AND SUBSEQUENTLY REPOSITIONED IN ANOTHER POSITION IN THE PATIENT'S SCALP. UPON SCREWING THE ELECTRODE BACK IN, THE HEALTH PROFESSIONAL NOTICED THAT IT WAS SCREWING BUT NOT STOPPING (INDICATES IT IS IN), TOOK HER HAND AWAY TO CHECK IF IT WAS IN, AND THE PLASTIC CAP AND CORD CAME AWAY WITH NO NEEDLE INSIDE. THE HEALTH PROFESSIONAL OBSERVED THAT THE NEEDLE ELECTRODE WAS STILL LODGED IN THE PATIENT'S SCALP. THEREAFTER, ATTEMPTS WERE MADE TO REMOVE THE NEEDLE ELECTRODE WITH FORCEPS, BUT EVENTUALLY A SMALL INCISION HAD TO BE MADE IN ORDER TO BE ABLE TO REMOVE THE NEEDLE ELECTRODE FROM THE SCALP.
Description of Event or Problem
THE CORKSCREW ELECTRODE WAS INSERTED INTO A PATIENT'S SCALP, WAS REMOVED, AND SUBSEQUENTLY REPOSITIONED IN ANOTHER POSITION IN THE PATIENT'S SCALP. UPON SCREWING THE ELECTRODE BACK IN, THE HEALTH PROFESSIONAL NOTICED THAT IT WAS SCREWING BUT NOT STOPPING (INDICATES IT IS IN), TOOK HER HAND AWAY TO CHECK IF IT WAS IN, AND THE PLASTIC CAP AND CORD CAME AWAY WITH NO NEEDLE INSIDE. THE HEALTH PROFESSIONAL OBSERVED THAT THE NEEDLE ELECTRODE WAS STILL LODGED IN THE PATIENT'S SCALP. THEREAFTER, ATTEMPTS WERE MADE TO REMOVE THE NEEDLE ELECTRODE WITH FORCEPS, BUT EVENTUALLY A SMALL INCISION HAD TO BE MADE IN ORDER TO BE ABLE TO REMOVE THE NEEDLE ELECTRODE FROM THE SCALP.
Description of Event or Problem
THE CORKSCREW ELECTRODE WAS INSERTED INTO A PATIENT'S SCALP, WAS REMOVED, AND SUBSEQUENTLY REPOSITIONED IN ANOTHER POSITION IN THE PATIENT'S SCALP. UPON SCREWING THE ELECTRODE BACK IN, THE HEALTH PROFESSIONAL NOTICED THAT IT WAS SCREWING BUT NOT STOPPING (INDICATES IT IS IN), TOOK HER HAND AWAY TO CHECK IF IT WAS IN, AND THE PLASTIC CAP AND CORD CAME AWAY WITH NO NEEDLE INSIDE. THE HEALTH PROFESSIONAL OBSERVED THAT THE NEEDLE ELECTRODE WAS STILL LODGED IN THE PATIENT'S SCALP. THEREAFTER, ATTEMPTS WERE MADE TO REMOVE THE NEEDLE ELECTRODE WITH FORCEPS, BUT EVENTUALLY A SMALL INCISION HAD TO BE MADE IN ORDER TO BE ABLE TO REMOVE THE NEEDLE ELECTRODE FROM THE SCALP.
Additional Manufacturer Narrative
THE CORKSCREW ELECTRODE WAS INSERTED INTO A PATIENT'S SCALP, WAS REMOVED, AND SUBSEQUENTLY REPOSITIONED IN ANOTHER POSITION IN THE PATIENT'S SCALP. UPON SCREWING THE ELECTRODE BACK IN, THE HEALTH PROFESSIONAL NOTICED THAT IT WAS SCREWING BUT NOT STOPPING (INDICATES IT IS IN), TOOK HER HAND AWAY TO CHECK IF IT WAS IN, AND THE PLASTIC CAP AND CORD CAME AWAY WITH NO NEEDLE INSIDE. THE HEALTH PROFESSIONAL OBSERVED THAT THE NEEDLE ELECTRODE WAS STILL LODGED IN THE PATIENT'S SCALP. THEREAFTER, ATTEMPTS WERE MADE TO REMOVE THE NEEDLE ELECTRODE WITH FORCEPS, BUT EVENTUALLY A SMALL INCISION HAD TO BE MADE IN ORDER TO BE ABLE TO REMOVE THE NEEDLE ELECTRODE FROM THE SCALP. THIS IS A FINAL REPORT (FOLLOW-UP NUMBER 1), INITIAL REPORT NUMBER: 9710376-2021-00002.
Remedial action
- Recall