3611 LITE GLOVE
Received Nov 17, 2016
Report 9612030-2016-00665 · MDR key 6109209
Device
Product problems
- Torn Material
Patient
Not reported
- Sepsis
- Sepsis
Narrative
Additional Manufacturer Narrative
SUBMIT DATE: 11/17/2016. AN INVESTIGATION IS CURRENTLY UNDER WAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED.
Description of Event or Problem
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH A LIGHT GLOVE. THE CUSTOMER REPORTS THAT THE DEVICE TORE OFF DURING SET UP. THERE WAS A RUPTURE OF ASEPSIS. THE PATIENT IS NOW IN HYPERTHERMIA. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2016 THE CUSTOMER STATES THAT THE LIGHT GLOVE HAS SPLIT DURING THE PROCEDURE AND THAT THE OUTCOME WAS SEPSIS OF THE PATIENT. CUSTOMER ALSO STATED THAT THE NURSES HAVE INSPECTED THE LIGHT GLOVE PRIOR TO USE; HOWEVER, THE TEAR APPEARED DURING THE PROCEDURE.