Description of Event or Problem · 1
OUR PT WITH A SOLID OVARIAN NODULE WAS ADMITTED FOR A DIAGNOSTIC LAPAROSCOPY; A LEFT SALPINGO-OOPHORECTOMY WAS PERFORMED. THE OPERATIVE PROCEDURE WAS UNEVENTFUL. FOLLOWING THE PROCEDURE, THE STERILE PROCESSING STAFF NOTED THAT THE TIP OF A STRYKER MANIPULATOR WAS NOT PRESENT ON FIRST INSPECTION; THEY BELIEVED THE PIECE TO BE BELOW THE OTHER PIECES OF CONTAMINATED EQUIPMENT IN THE CONTAMINATED TRAY. FOLLOWING THE LAST CASE OF THE DAY, THEY NOTED THE TIP TO BE ABSENT AND NOTIFIED THEIR SUPERVISOR. THEY BELIEVED IT TO BE IN ONE OF THE GARBAGE BAGS. TWO DAYS LATER, OUR PT TELEPHONED TO TELL US THAT UPON STRAINING TO HAVE A BOWEL MOVEMENT, SOMETHING FELL FROM HER VAGINA AND SHE RETRIEVED A PIECE OF WHITE PLASTIC ATTACHED TO SOME METAL---THE TIP OF THE STRYKER ACORN MANIPULATOR THAT WAS MISSING. OF COURSE, SHE WAS UPSET AND DISTRESSED. THE STAFF RN NOTIFIED THE SUPERVISOR WHO PAGED/NOTIFIED THE PHYSICIAN IMMEDIATELY. AFTER A SECOND PHONE CALL AND REASSURANCE FROM OUR NURSE AND QUESTIONING REGARDING ANY SYMPTOMS OR BLEEDING, SHE WAS ADVISED TO CALL HER PHYSICIAN THE NEXT MORNING. THE PT WAS EVALUATED BY HER OPERATING PHYSICIAN THE NEXT DAY; THERE WERE NO SIGNS OF ANY INJURY TO THE VAGINA OR ANY TISSUES AS A RESULT OF THIS INCIDENT. THE PHYSICIAN APOLOGIZED. THE ROOT CAUSE ANALYSIS BEGAN IMMEDIATELY. UPON EVALUATION OF ANOTHER MANIPULATOR MANUFACTURED BY PILLING-WECK, IT WAS DETERMINED THAT THE ACORN TIP "SCREWED" ON THREADS, 360 PLUS 180 DEGREES. THE STRYKER ACORN TIP TURNED ON ONLY APPROX 180 DEGREES; WE BELIEVE THIS TO BE A DESIGN PROBLEM. WE SPECULATED THAT WITH THE MANIPULATION THAT OCCURS DURING THIS TYPE OF PROCEDURE THAT THE TIP DISCONNECTED FROM THE BODY OF THE MANIPULATOR. WE MADE CONTACT WITH THE VICE PRESIDENT AT STRYKER, WHO WAS AWARE OF THE INCIDENT FROM THIS SALES REPRESENTATIVE; WE ASKED WHETHER THIS OCCURRENCE WOULD BE REPORTED TO MEDWATCH AND WE WERE INFORMED, IT WOULD NOT; IT DIDN'T MEET THE MANUFACTURER'S CRITERIA FOR REPORTING. THEREFORE, IT WAS OUR MEDICAL DEVICE REPORTING TEAM'S DECISION TO REPORT THIS OCCURRENCE, DESPITE NO PT INJURY, AS AN OPPORTUNITY FOR IMPROVEMENT TO ENCOURAGE EVALUATION OF THE THREADS OR LACK THEREOF, THAT ATTACH THE BODY OF THE MANIPULATOR TO THE ACORN TIP. THE VICE PRESIDENT AT STRYKER WAS INFORMED OF THAT FACT ON 11/21/06. HE NOTED THAT HE WOULD RECOMMEND A RE-EVALUATION OF THE CONNECTION WHEN STRYKER REC'D THEIR NOTICE OF THIS REPORT. ACTION AND FOLLOW-UP: STAFF MEETING WAS HELD WITH THE VICE PRESIDENT OF THE FACILITY ON 11/13/06. ROOT CAUSE ANALYSIS CONTINUED ON 11/16/06 WITH THE OPERATING ROOM TEAM. STAFF EDUCATION AND POLICY CHANGE TO INCLUDE INSTRUMENT COUNT WITH ALL PROCEDURES BEGINNING 11/17/06.