THD SLIDE DOPPLER PROBE 10 SHOTS NON STERILE
Received Feb 9, 2015 · Event occurred Feb 13, 2012
Report 3006680097-2015-00005 · MDR key 4524386
Product problems
- Loose or Intermittent Connection
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THIS REPORT IS RELATED TO A 10 SHOTS REUSABLE DOPPLER PROBE, WITH 4 SHOTS STILL AVAILABLE (ALREADY USED 6 TIMES). THE CUSTOMER REPORTED THAT WHILE THE DOCTOR WAS PERFORMING THE CASE, THE CONNECTOR OF THE PROBE WAS LOOSE. THE STAFF NEEDED FEW ATTEMPTS OF TURNING AND TWISTING THE CONNECTOR IN ORDER TO REGAIN THE OPERATION OF THE PROBE (HEARING THE SOUND AGAIN). THE TREATMENT WAS THEN TERMINATED SUCCESSFULLY WITH THE SAME DEVICE WITH NO IMPACT ON THE PATIENT OUTCOME. AT THE END OF THE TREATMENT THE PROBE WAS DISPOSED, SO IT WAS NOT AVAILABLE FOR TECHNICAL INVESTIGATION.
Additional Manufacturer Narrative
FOLLOWING A COMPLAINT RETROSPECTIVE REVIEW WE BECAME AWARE THAT IN THE ORIGINAL HANDLING OF THIS COMPLAINT NO MDR WAS SENT TO FDA. THE INVESTIGATION OF THIS REPORT BY OUR TECHNICAL DEPARTMENT CONCLUDED THAT THE DEVICE WAS IMPROPERLY USED AND THEN DAMAGED. WE CAN CONCLUDE THEREFORE THAT THE REPORTED EVENT IS NOT THD RESPONSIBILITY.