SAMMONSPRESTON ROLYAN
Received Nov 9, 2018 · Event occurred Sep 5, 2018
Report 3032391-2018-00016 · MDR key 8055063
Device
Generic name
Expressaire Tourniquet Cuff, Single Port, Long Leg, W/ll, No Stockinette, (blue)
Manufacturer
Medline RenewalCatalog number
A70107010R
Lot number
UNK
Product problems
- Leak/Splash
Patient
Not reported
- No Code Available
- No Code Available
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE REPROCESSED SAMMONS PRESTON ROLYAN EXPRESSAIRE TOURNIQUET CUFF WAS USED FOR APPROXIMATELY 10 MINUTES FOR AN ARTHROSCOPIC MENISCUS REPAIR. PER REPORT, LEAKING WAS NOTED COMING FROM THE CUFF'S PORT. THE SURGICAL PROCEDURE WAS CANCELLED AND HAD TO BE RESCHEDULED. THE PATIENT WAS REPORTEDLY UNDER GENERAL ANESTHESIA FOR THE PROCEDURE. THERE WAS NO REPORT OF ANY ADVERSE PATIENT CONSEQUENCE AND NO EFFECT ON THE PATIENT'S STABILITY AS A RESULT OF THE INCIDENT. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. THE SAMPLE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. THE LOT NUMBER ASSOCIATED WITH THE DEVICE WAS NOT REPORTED. A REVIEW OF THE REPROCESSING RECORDS COULD NOT BE PERFORMED. A ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT THE REPROCESSED SAMMONS PRESTON ROLYAN EXPRESSAIRE TOURNIQUET CUFF STARTED TO LEAK AND THE ARTHROSCOPIC MENISCUS REPAIR WAS CANCELLED.