SLK-6-LF SMART BAND LIGATION KIT

Additional Manufacturer Narrative

THE BAND WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. HOWEVER, THE INSTRUCTION MANUAL WARNS USERS TO ¿VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE.¿

Description of Event or Problem

OLYMPUS WAS INFORMED THAT A PATIENT SUSTAINED TRAUMA TO THE LARYNX AND UPPER ESOPHAGEAL CENTER AFTER UNDERGOING A THERAPEUTIC ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH BANDING. ONCE THE PATIENT WAS REMOVED FROM THE PROCEDURE ROOM, THE PHYSICIAN OBSERVED BLEEDING AROUND THE BAND. THE PATIENT WAS SENT TO RECOVERY FOR ABOUT A HALF AN HOUR AND THE BLEEDING SUBSIDED ON ITS OWN. NO ADDITIONAL INTERVENTION WAS REQUIRED. THE PATIENT WAS THEN DISCHARGED HOME. IN ADDITION, IT WAS REPORTED THAT DURING THE PROCEDURE THE PHYSICIAN EXPERIENCED DIFFICULTY WHILE INSERTING/ WITHDRAWING THE SCOPE. IT WAS REPORTED THAT THE PHYSICIAN BELIEVES THAT THE SMART BAND CAUSED THE SCOPE TO BECOME STUCK AND RESULTED IN THE PATIENT¿S INJURY.

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO CORRECT THE PREVIOUSLY REPORTED PROCODE FROM MND TO HRB.

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO REPORT ADDITIONAL INFORMATION PROVIDED BY THE ORIGINAL EQUIPMENT MANUFACTURER (OEM). THE OEM WAS UNABLE TO DETERMINE THE EXACT CAUSE FOR THE PATIENT¿S OUTCOME AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE OEM REPORTED THAT THE BAND IS MADE OF NON-LATEX, SOFT ELASTOMERIC MATERIAL AND IS ATRAUMATIC. THE OEM REVIEWED THE CONTENT OF THIS COMPLAINT FILE TO PERFORM A POSSIBLE ROOT CAUSE INVESTIGATION. IT WAS DETERMINED THAT THE REPORTED EVENT IS LIKELY ATTRIBUTED TO THE PATIENT¿S PREEXISTING CONDITION THAT CAUSES COAGULOPATHY. THE OEM REPORTED THAT DUE TO INSUFFICIENT INFORMATION BEING PROVIDED BY THE USER FACILITY THE THEORY OF THE PATIENT¿S CONDITION AS THE POSSIBLE CAUSE COULD NOT BE CONFIRMED. HOWEVER, THIS IS A KNOWN COMPLICATION AND IS LISTED IN THE INSTRUCTION MANUAL UNDER THE ¿CONTRADICTION¿ SECTION. THE INSTRUCTION MANUAL WARNS USERS THAT ¿POTENTIAL COMPLICATIONS FOR THIS PROCEDURE INCLUDE, BUT ARE NOT LIMITED TO RETROSTERNAL PAIN, NAUSEA, LARYNGEAL LACERATION, ESOPHAGEAL PERFORATION, STRICTURE FORMATION, OBSTRUCTION OR ULCERATION.¿ IN ADDITION, THE OEM PERFORMED A REVIEW THE DHR AND FOUND NO ANOMALIES DURING THE MANUFACTURING OF THE SUBJECT DEVICE AND LOT NUMBER. THIS PHENOMENON IS UNCOMMON AND NO FURTHER ACTION IS REQUIRED.