MalfunctionJOS
ELECTRODE EXTENSION - 11"
Received Apr 13, 2012
Report 1717344-2012-00491 · MDR key 2542486
Device
Product problems
- Component Falling
- Loose or Intermittent Connection
- Stretched
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE LENGTH OF THE EXTENDER HAS STRETCHED OUT. THIS HAS OCCURRED AFTER ABOUT FOUR USES. AS A RESULT, THE COATED BLADE ELECTRODE THAT WAS PLACED IN THE EXTENDER HAD A LOOSE FIT AND FELL INTO THE PATIENT CAVITY. THE ELECTRODE WAS RETRIEVED. NO PATIENT INJURY OCCURRED.
Additional Manufacturer Narrative
(B)(4). TO DATE, THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.