NS-3600-B LITE GLOVE 1000/CASE
Received Oct 3, 2016 · Event occurred Sep 26, 2016
Report 9612030-2016-00486 · MDR key 5995393
Product problems
- Torn Material
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
SUBMIT DATE: 10/3/2016. 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 LITE GLOVE. THE CUSTOMER REPORTS LIGHT HANDLE COVERS SPLITTING. THE ENDS ARE TEARING AND APPEAR THINNER THAN THE REST OF THE HANDLE. THERE WAS NO PATIENT INVOLVED AND NO MEDICAL INTERVENTION.
Additional Manufacturer Narrative
PER ADDITIONAL INFORMATION RECEIVED THE CUSTOMER REPORTED THERE WAS NO FEELING OF THE GLOVE BEING TOO TIGHT, IT FELT NORMAL. IT WAS FOUND AFTER THE PATIENT WAS IN THE ROOM. THERE WAS NO INCISION MADE IN THE PATIENT. THE SPLIT WAS DISCOVERED AFTER THE PATIENT WAS DRAPED, BUT BEFORE THE INCISION WAS MADE. UNFORTUNATELY A MEDTRONIC DEVICE WAS HANDED OFF TO THE ASSISTANT WHO WAS CONTAMINATED FROM THE SPLIT LIGHT HANDLE COVER. THE SPLIT WAS DISCOVERED BEFORE THE DEVICE WAS IMPLANTED, SO ANOTHER STERILE DEVICE WAS OPENED. A NEW GLOVE WAS PLACED, RE-STERILIZED THE FIELD AND THE DOCTOR RESCRUBBED IN. IT WAS BEING USED WITH SKYTRON LIGHTS THAT WE HAVE HAD FOR YEARS. THE CONTAMINATION WAS CAUGHT ON TIME, THE CUSTOMER REPORTED HE DOES NOT BELIEVE THERE WAS ANY ADDITIONAL PATIENT TREATMENT WITH ANTIBIOTICS.