PENA MUSCLE STIMULATOR PROBE (NOT STERILE)
Received Feb 24, 2014
Report 9612007-2014-00009 · MDR key 3902049
Device
Generic name
Pena Muscle Stimulator Probe
Manufacturer
Integra Neurosciences Implants S.a.Catalog number
PS-2P
Product problems
- Device Operates Differently Than Expected
- Scratched Material
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.
Description of Event or Problem
THE EIGHTH REPORT OF EIGHT FROM THE SAME FACILITY INVOLVING PENA PROBE. CROSS REFERENCE WITH MFR. REPORT 9612007-2014-00003. A REPORT WAS RECEIVED FROM A CHILDREN'S HOSPITAL THAT THE PENA PROBE STOPPED/DIDN'T WORK. THE CONSULTANT SURGEON CUT THE CABLE AND EXPOSED THE INNER CABLING WHICH APPEARED TO BE OXIDIZED. THE PROBE WAS IN CONTACT WITH A PATIENT (AGE OF THE PATIENT IS NOT AVAILABLE). THERE WAS A DELAY WHILE THE STAFF LOCATED ANOTHER PROBE TO USE. THERE WAS NO INJURY INVOLVED AS A RESULT OF THE DELAY.