Additional Manufacturer Narrative · 1
MIZUHO AMERICA, INC. PURCHASES THE 07-824-02 MONOPOLAR COAGULATOR FROM MIZUHO MEDICAL WHO PURCHASES THE PRODUCT FROM LOGAN INSTRUMENTS, INC., A UNITED STATES BASED MFR. MIZUHO MEDICAL INSPECTS, PACKAGES AND STORES THE PRODUCT. MIZUHO AMERICA, INC. DISTRIBUTES THE DEVICE TO MEDICAL FACILITIES. MIZUHO AMERICA, INC. REVIEWED ALL INSPECTION REPORTS RELATING TO 07-824-02 MONOPOLAR COAGULATOR AND THERE WERE NO MATERIAL NON-CONFORMANCES OBSERVED. MIZUHO AMERICA REVIEWED ALL EXISTING INVENTORY AND THERE WERE NO INSTANCES OF COMPROMISED INSULATION. MIZUHO AMERICA, INC. HAS SOLD THIS REUSABLE DEVICE FOR 10 YEARS. UPON REVIEW OF ALL COMPLAINT RECORDS, THERE IS NO INSTANCE OF AN INSULATION FAILURE. THIS INSTRUMENT WAS SOLD TO THE FACILITY ON JANUARY 12, 2007. AS A RESULT OF DISCUSSIONS WITH THE FACILITY, IT WAS DETERMINED THAT TRANSSPHENOIDAL SURGERY IS PERFORMED AND THIS DEVICE IS REUSED TWICE A WEEK ON AVERAGE. THE REUSABLE DEVICE IS CLEANED AND STERILIZED PER HOSP PROTOCOL. THE ACTUAL DEVICE WAS NOT RETURNED TO MIZUHO AMERICA, INC. FROM THE FACILITY. AN EVAL OF THE DEVICE COULD NOT OCCUR. IT IS POSSIBLE THAT THE DEVICE WAS DAMAGED DURING THE RESTERILIZATION PROCESS AT THE FACILITY. THE FACILITY PURCHASED AN ADD'L THREE MORE IN APRIL 2007 WITHOUT INCIDENT. MIZUHO AMERICA, INC. DOES NOT BELIEVE THIS EVENT MEETS THE REQUIREMENTS OF A REPORTABLE EVENT BECAUSE A DEVICE FAILURE WILL NOT LIKELY RESULT IN A DEATH, SERIOUS INJURY OR OTHER SIGNIFICANT ADVERSE EVENT EXPERIENCE. ACCORDING TO THE FACILITY MEDWATCH FORM, THE PT SUSTAINED A MINOR BURN, WHICH DID NOT NECESSITATE MEDICAL OR SURGICAL INTERVENTION.