inforMED

CRYOBLASTATION

Received Feb 1, 2005 · Event occurred Nov 16, 2004

Report MW4003884 · MDR key 574190

Device

Generic name

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Manufacturer

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Model number

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Catalog number

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Lot number

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Product problems

  • Misapplication

Patient

78 YR

  • Bacterial Infection
  • Fistula
  • Necrosis
  • Nerve Damage
  • Injury
  • Surgical procedure
  • Colostomy
  • Hospitalization required

Narrative

Description of Event or Problem

PT WAS TREATED USING CRYOBLASTATON PROSTATECTOMY. A GRIEVOUS MECHANICAL OR JUDGEMENT ERROR OCCURRED IN THE SURGICAL ROOM AS THE ICE BALL FORMED FAR BEYOND THE TYPICAL LIMITS OF THE PROSTATE. PT IS NOW UNDER TREATMENT, INCLUDING EXTENSIVE RECONSTRUCTIVE SURGERY, TO REPAIR AN OBLITERATED BLADDER, DESCENDING COLON, RECTUM AND SURROUNDING TISSUE. AT THIS TIME THE OUTCOME OF THIS RECONSTRUCTION IS NOT KNOWN AND PT MAY HAVE A PERMANENT COLOSTOMY AND RENAL CATHETERS. PT'S CONDITION WAS WORSENED BY THE CAVALIER ATTITUDE EXHIBITED BY DR AND HIS STAFF DURING POST SURGICAL CARE AND OBSERVATION. IN SHORT, THE DOCTORS FAILED OR REFUSED TO ACCEPT THE POSSIBILITY THAT POST SURGICAL COMPLICATIONS WERE PRESENT. SUBSEQUENTLY, PT WAS LEFT WITH NECROTIC TISSUE WITHIN THEIR ABDOMEN AND SEVERAL FISTULAS FROM BLADDER TO THE DESCENDING COLON. SEEPAGE OF STOOL INTO LOWER ABDOMEN INFECTED THE FEMORAL ARTERY, SCIATIC NERVE AND MUSCLE TISSUE OF LEFT LEG RENDERING IT USELESS. SEVEN WEEKS AFTER THE PROCEDURE PT WAS ADMITTED TO ANOTHER HOSP. EMERGENCY PROCEDURES TO REDUCE THE INFECTION AND DIVERT THEIR STOOL AND URINE. THIS HOSP ADMISSION CAME AFTER FOUR VISITS TO PROCEDURE FACILITY INVOLVING SERIOUS COMPLAINTS ABOUT PT'S DECLINING HEALTH. TWO ATTEMPTS WERE MADE DIRECTLY TO DR REQUESTING IMMEDIATE ADMISSION TO PROCEDURE FACILITY TO CONTROL, DIAGNOSE, AND RECTIFY POST SURGICAL COMPLICATIONS. THE ENTIRE SCENARIO OF THIS CASE IS WELL DOCUMENTED BY THE PHYSICIANS.