PENA MUSCLE STIMULATOR PROBE (NOT STERILE)
Received Feb 24, 2014
Report 9612007-2014-00010 · MDR key 3902047
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
Description of Event or Problem
THE THIRD 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.
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.