3611 LITE GLOVE
Received Sep 26, 2016
Report 9612030-2016-00458 · MDR key 5976448
Device
Product problems
- Torn Material
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
SUBMIT DATE: 9/26/2016. AN INVESTIGATION IS CURRENTLY UNDERWAY. 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 STATES: THE PRODUCT RIPS APART WHEN PUTTING IT ON THE LIGHT HANDLE. WHILE SOME WORK, OTHERS COULDN'T GET OVER THE HANDLE AND RIP. HAS THE PRODUCT BEEN RE-STERILIZED PRIOR TO THIS INCIDENT ? NO WAS THE COMPLAINT PRODUCT USED ON A PATIENT? NO. IF THE PRODUCT WAS USED ON A PATIENT: PERSON INJURED OR JEOPARDIZED? NO. EXTENSION OF THE SURGERY TIME BY MORE THAN 30MIN. OR RE-OPERATION NECESSARY? NO. BLOOD LOSS FOR MORE THAN 250CC? NO EXTENSION OF THE INCISION BY MORE THAN 1 INCH? NO. CHANGE FROM ENDOSCOPIC TO OPEN SURGERY? NO. UNANTICIPATED TISSUE LOSS OR IRREVERSIBLE DAMAGE? NO. ANY PORTION OF THE DEVICE OR TACK FALL INTO PATIENT CAVITY? NO IF YES, WERE THE PIECES/TRACKS RETRIEVED FROM THE PATIENT? YES. WAS ANY REINFORCEMENT MATERIAL USED IN CONJUNCTION WITH THE STAPLING DEVICE? NO.