THD REVOLUTION
Received Oct 11, 2017 · Event occurred Aug 26, 2017
Report 3006680097-2017-00001 · MDR key 6940807
Product problems
- Misassembly by Users
- Misassembly by Users
Patient
Not reported
- Superficial (First Degree) Burn
- Superficial (First Degree) Burn
Narrative
Additional Manufacturer Narrative
THE THD SYSTEM INVOLVED IN THE EVENT IS BASED ON THE DOPPLER-GUIDED LOCATION AND LIGATION OF THE TERMINAL BRANCHES OF THE SUPERIOR HAEMORRHOIDAL ARTERY USING THE THD EVOLUTION OR THD REVOLUTION DEVICES AND THEIR COMPATIBLE SINGLE-USE KITS. THEN, THD EVOLUTION AND THD REVOLUTION DEVICES ARE USED IN CONJUNCTION WITH DEDICATED INSTRUMENTS, SUCH AS THD KIT, THD FIBER OPTIC CABLE AND THD DOPPLER PROBE. IN PARTICULAR, IN THE THD SYSTEM, THE FIBER OPTIC CABLE IS CONNECTED TO THE THD EVOLUTION AND THD REVOLUTION DEVICES AND, BY COUPLING THE TIP ON THE HANDLE OF THE THD SLIDE PROCTOSCOPE, IT ACTS AS AN ILLUMINATOR OF THE OPERATING FIELD. WE HAVE CONSIDERED AS OBJECT OF THIS REPORT THE ONLY DEVICE PART OF THE SYSTEM NOT DISPOSED BY THE FACILITY AT THE END OF THE TREATMENT (THD REVOLUTION).
Description of Event or Problem
AT THE END OF THE PROCEDURE, THE SURGEON FOUND A SUPERFICIAL BURNT ON THE PATIENT SKIN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT BURN WOUND WAS DRESSED.