FDA Adverse Event Death Summary report: N

KARL STORZ ENDOSCOPY

MDR report key: 967409 · Received October 2, 2006

Report

Report Number
967409
Event Type
Death
Date Received
October 2, 2006
Date of Event
January 24, 2003
Report Date
October 2, 2006
Manufacturer
KARL STORZ
Product Code
FJL
Adverse Event
Yes
Product Problem
Yes
Report Source
User Facility report
Reporter Location
RI, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

IN 2003, THIS PT UNDERWENT A CYSTOSCOPY WITH BLADDER BIOPSIES. A KARL STORZ ENDOSCOPY RESECTOSCOPE SHEATH WAS USED DURING THIS PROCEDURE. THE PT HAD AN UNEVENTFUL POST-OPERATIVE COURSE AND WAS DISCHARGED TO HOME ON TWO DAYS LATER. IN 2006, THIS PT WAS READMITTED FOR A SCHEDULED CYSTOSCOPY DUE TO GROSS HEMATURIA, BLADDER INFECTION WITH BLADDER STONE AND HISTORY OF STRICTURE DISEASE. DURING THE CYSTOSCOPY PROCEDURE, A MICRON LASER FIBER WAS INTRODUCED AND FRAGMENTATION OF THE OUTER CRUST OF THE BLADDER STONE REVEALED AN APPARENT WHITE PLASTIC MATERIAL. THE FOREIGN BODY COULD NOT BE REMOVED VIA URETHRA, THUS OPEN CYSTOLITHOTOMY WAS PERFORMED. THE WHITE OBJECT WAS THE CERAMIC TIP OF THE RESECTOSCOPE SHEATH USED IN THE 2003 SURGICAL PROCEDURE. THE PT WAS DISCHARGED TO HOME IN 2006. ON THE FOLLOWING DAY, THIS PT WAS IN THE SURGEON'S OFFICE FOR A FOLLOW-UP VISIT AND WAS NOTED TO HAVE SHORTNESS OF BREATH AND DYSPNEA. HE WAS SENT TO THE EMERGENCY ROOM AND REPORTED DIZZINESS, WEAKNESS AND FATIGUE SINCE THE SURGICAL PROCEDURE ON THREE DAYS EARLIER. HE WAS ADMITTED TO THE ICU WITH DIAGNOSIS OF PNEUMONIA, DEHYDRATION AND EVOLVING MI. ON FOUR DAYS LATER, HE WAS NOTED TO BE IN CONGESTIVE HEART FAILURE, BUT STABLE ENOUGH FOR TRANSFER FROM ICU. ON THE NEXT DAY, CT SCAN SHOWED MULTIPLE BILATERAL PULMONARY EMBOLI AND TREATMENT WITH LOVENOX WAS STARTED. ONE DAY LATER, THE PT WAS STARTED ON COUMADIN AND ON THE NEXT DAY, THE LOVENOX WAS CHANGED TO HEPARIN. ON THE SAME DAY, THE PT DEVELOPED GROSS HEMATURIA AND CLOT RETENTION. ONE DAY LATER, URETHRAL DILITATION, CYSTOSCOPY AND EVACUATION OF CLOT WAS PERFORMED IN THE OPERATING ROOM. ON THE FOLLOWING DAY, THE PT DEVELOPED HYDRONEPHROSIS AND ACUTE RENAL FAILURE, WHICH RESOLVED BY TWO DAYS LATER. ON THE NEXT DAY, AT 02:45 AM THE PT WAS RETURNED TO THE OR FOR CYSTOSCOPY AND CLOT EVACUATION AND TRANSFERRED TO ICU POST-OPERATIVELY. LATER THAT DAY THE PT WAS RETURNED TO THE OR FOR GREENFIELD FILTER PLACEMENT. PRIOR TO TRANSFER TO THE OR TABLE THE PATIENT BECAME UNRESPONSIVE AND RESUSCITATION WAS UNSUCCESSFUL. IT SHOULD BE NOTED THAT THE WESTERLY HOSPITAL HAS HAD OTHER EXPERIENCE WITH BROKEN CERAMIC TIPS ON RESECTOSCOPE SHEATHS FROM THIS MANUFACTURER. DOCUMENTATION OF THESE IS ATTACHED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 KARL STORZ ENDOSCOPY RESECTOSCOPE SHEATH FJL KARL STORZ 27040BO NA

Patients

Seq Age Sex Outcome Treatment
1 80 YR Death| H