PRODUCT COMPLAINT # (B)(4). ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION.? TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. CAN YOU PLEASE CLARIFY WHEN THE PROBE TIP BROKE OFF THE DEVICE (AFTER THE PROCEDURE, DURING USE IN THE CASE, IN THE PATIENT, ETC.)? IF THE PROBE TIP BROKE DURING THE PROCEDURE, WAS THE TIP REMOVED FROM THE PATIENT? DID REMOVAL CAUSE ANY CHANGES TO THE PATIENT CARE? WAS THERE ANY PATIENT CONSEQUENCE OR CHANGE IN THE POST-OPERATIVE CARE OF THE PATIENT AS A RESULT OF THE EVENT? ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.
D
Patient 1
IT WAS REPORTED THAT THE CUSTOMER ALERTED THE SALES REP THAT THEY WERE GETTING REPETITIVE "REFLECTED POWER ERRORS" ON ONE OF THE TWO PROBES BEING USED IN A MICROWAVE ABLATION PROCEDURE. TO MITIGATE, THE SALES REP RECOMMENDED THEY MAKE SURE GREEN PORTION OF PROBE FULLY WAS EMBEDDED IN TISSUE. CUSTOMER CONTINUED TO GET ERRORS. CUSTOMER ALSO MENTIONED THAT IT APPEARED PLASTIC SHEATHING WAS TORN AROUND DISTAL CANNULA AND TIP APPEARED VERY CHARRED. CUSTOMER REPORTED THE RP ERRORS STARTING AT ABOUT SEVEN MINUTES INTO A TEN MINUTE CYCLE. CUSTOMER ALSO NOTED TEMPS REACHING 170 C DURING CYCLE. DECISION WAS MADE TO DISCARD PROBE AND REPLACE WITH A NEW PROBE. FINAL THREE MINUTES OF CYCLE WERE COMPLETED WITHOUT INCIDENT. THE PROCEDURE WAS DELAYED BY APPROXIMATELY TEN MINUTES AND WAS COMPLETED WITH NO PATIENT CONSEQUENCES REPORTED. UPON EXAMINING THE PROBE, THE SALES REP NOTICED THAT THE DISTAL 5 MM THE TIP OF THE PROBE WAS MISSING AND ALERTED THE CUSTOMER.