LAPAROSCOPIC CHOLECYSTECTOMY KIT
Received Dec 7, 2015 · Event occurred Sep 1, 2015
Report 5270146 · MDR key 5270146
Device
Product problems
- Manufacturing, Packaging or Shipping Problem
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
OVER A PERIOD OF TIME, OUR OPERATING ROOM STAFF HAVE IDENTIFIED INCORRECT SPONGE COUNTS RIGHT OUT OF THE PACKAGE. WE HAVE BEEN REPORTING THEM VIA MEDSUN. OUR CUSTOM SURGICAL PACK OPERATIONS COMPANY ASKED FOR A MEETING REGARDING OUR PROBLEMS WITH SPONGE COUNTS AND WE DID SO THIS MONTH. THEY EXPLAINED QUITE IN DETAIL WHAT THEY HAVE BEEN DOING FOR THE LAST FEW MONTHS TO MITIGATE THIS PROBLEM. IN SUMMARY, OUR VENDOR PUTS TOGETHER THE PACKS, OPENS THE SPONGE PACKS RECEIVED FROM THE MANUFACTURER AND COUNTS TWICE ON THEIR ASSEMBLY LINE. ONE PERSON COUNTS, THEN IT GOES TO THE NEXT PERSON TO COUNT. OUR OPERATING ROOM STAFF EDUCATORS HAVE SHARED THIS WITH OUR STAFF; OUR COUNTS ARE DONE BY LAYING OUT THE SPONGES SEPARATELY ON A FLAT SURFACE. AT THIS TIME, WE ARE SEEING FEWER INCIDENCES OF INCORRECT NUMBERS OF SPONGES IN PACKS AND WE HOPE THE PROBLEMS HAVE BEEN RESOLVED.