Description of Event or Problem · 1
DEVICE WAS BRAND NEW, USED FOR THE FIRST TIME. IN COMPLIANCE WITH MDR REGULATIONS, PPIC IS HEREBY SUBMITTING THIS INFO CONCERNING AN "EVENT" WHICH HAS OCCURRED DURING AN ENDOSCOPIC PROCEDURE INVOLVING PRODUCT(S) SOLD UNDER PENTAX PRECISION INSTRUMENT CORP BRAND NAME, MFG BY GIP IN GERMANY. AT THE PRESENT TIME DIST HAS NOT REC'D ANY WRITTEN REPORT CONCERNING THIS EVENT. ALL DETAILS WHICH FOLLOW ARE BASED UPON A CONVERSATION WITH INITIAL REPORTER. DURING AN ERCP PROCEDURE A STONE WAS FOUND IN A PT'S COMMON BILE DUCT. AFTER THE STONE WAS "CAPTURED" WITHIN THE BASKET AND THE LITHOTRIPTOR HANDLE WAS "CRANKED" IN AN ATTEMPT TO CRUSH THE STONE, THE LITHOTRIPTOR WIRE SNAPPED. WHEN THE METAL SPIRAL WAS WITHDRAWN FROM THE DUODENOSCOPE, A TWELVE TO EIGHTEEN INCH LENGTH OF FRAYED WIRES WAS LEFT PROTRUDING FROM THE ENDOSCOPE'S CHANNEL INLET. THE WIRE HAD SNAPPED AND WAS COMPLETELY SEVERED AT APPROX 73 INCHES FROM THE DISTAL END. SUBSEQUENTLY, AN ATTEMPT WAS MADE TO FREE THE STONE FROM THE BASKET. HOWEVER, WHEN THIS WAS UNSUCCESSFUL THE PT HAD TO HAVE OPEN SURGERY TO REMOVE THE WIRE/BASKET AS WELL AS SEVERAL STONES RETAINED IN THE GALL BLADDER. ACCORDING TO THE CUSTOMER, THIS WAS THE FIRST TIME THIS LITHOTRIPTOR BASKET WAS USED. THIS INFO IS PRELIMINARY AND ANY OTHER DETAILS AS WELL AS PRODUCT SAMPLES WILL BE SENT TO FDA'S ATTENTION AFTER RECEIPT. A COPY OF THIS EVENT WILL ALSO BE SENT TO MEDIGLOBE IN TEMPE, AZ.