Description of Event or Problem · 0
THE PATIENT WAS SCHEDULED FOR A PROCEDURE AT A CLINIC THAT WAS A CUSTOMER OF OUR U.S. DISTRIBUTOR. DURING THIS PROCEDURE, IT WAS REPORTED THAT THE PROVIDER FOLLOWED STANDARD PROTOCOL IN THE PREPARATION OF THE PATIENT AND IN THE USAGE OF THE CANNULAE. A 5 MM CANNULA WAS PLACED INTO THE PATIENT'S UTERUS UNDER ULTRASOUND GUIDANCE. CORRECT POSITIONING WAS CONFIRMED IN THE INITIAL REPORT TO THE DISTRIBUTOR, BY "PALPATING THE FUNDUS TO ENSURE IT WAS IN THE PROPER LOCATION." HOWEVER, WHEN THE PROVIDER "CONNECTED THE ASPIRATOR DEVICE, THE TWO COMPONENTS SEPARATED AS (THEY) APPLIED SUCTION. SPECIFICALLY, THE WHITE TOP PIECE DETACHED FROM THE CLEAR TUBE PORTION OF THE DEVICE [ASPIRATOR]." IN THE OPINION OF THE PROVIDER, IN THEIR ORIGINAL REPORT, SHE HYPOTHESIZED THAT "THE OPPOSING FORCES INVOLVED IN THE DETACHMENT LIKELY CAUSED UTERINE PERFORATION." THE PROVIDER THEN REQUESTED A REPLACEMENT DEVICE, CONFIRMED ITS PROPER FUNCTIONALITY, AND THEY ADVANCED IT, STILL UNDER ULTRASOUND GUIDANCE. THE PROVIDER NOTED THAT SHE FELT A SIGNIFICANT LOSS OF RESISTANCE, WHICH STRONGLY SUGGESTED THAT THE PREVIOUS INCIDENT HAS RESULTED IN A PERFORATION. BASED ON THIS FEELING, THE PROVIDER IMMEDIATELY ABORTED THE PROCEDURE TO PREVENT FURTHER INJURY TO THE PATIENT. THE DECISION WAS MADE TO TRANSPORT THE PATIENT TO A HOSPITAL FOR EVALUATION. IN FOLLOW-UP DISCUSSIONS, IT WAS CONFIRMED THAT COAGULATION WAS USED TO STOP THE BLEEDING AT THE TIME, AND THERE WERE "NO OTHER SIGNS OF INJURY NOTED." THE PATIENT WAS DISCHARGED AFTER SURGERY ON THE SAME DAY AT ADMITTANCE, AND IT WAS "UNLIKELY TO SEE FURTHER ISSUE AS FULL INTRA-ABDOMINAL SURVEY WAS PERFORMED." ADDITIONALLY, WHEN THE DISTRIBUTOR RECEIVED THE DAMAGED ASPIRATOR BACK TO RETURN FOR FULL INVESTIGATION, THEY REPORTED THAT ONE (1) "OF THE NOTCHES ON THE COLLAR STOP IS BROKEN." AND THAT THE DEVICE APPEARED TO "WORK JUST FINE OTHER THAN THAT." THIS TYPE OF DAMAGE TO THE DEVICE WOULD TYPICALLY BE EXPECTED TO BE NOTICED PRIOR TO USE OF THE DEVICE, AS IT WAS EXPLAINED THAT THE ASPIRATOR IN QUESTION HAD BEEN USED PREVIOUSLY AND DISASSEMBLED/RE-STERILIZED/REASSEMBLED PRIOR TO USE IN THE PROCEDURE-IN-QUESTION. DEVICE WAS RETURNED TO CONTRACT MANUFACTURER FOR FULL INVESTIGATION.