BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT HPS

    MDR report key: 1163096 · Received September 16, 2008

    Report

    Report Number
    2937094-2008-00004
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    August 7, 2008
    Report Date
    August 8, 2008
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER- SILICON VALLEY
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO PROVIDED BY THE DR TO AMS IS AS FOLLOWS: THE PT'S PROSTATE WAS SIZED AT AROUND 50 GRAMS. THE LATERAL LOBES WERE "KISSING" AND THE DR STARTED IN THE MIDDLE OF THE LOBES, APPROX IN THE CENTER OF THE PROSTATE, IN ORDER TO CREATE A CHANNEL. HE HEARD A COUPLE OF "ZINGS". THE PROCEDURE TIME HAD ONLY BEEN 1.5 MINS WHEN THEY NOTICED THE FIBER TIP WAS "BLACKENED". THE FIBER WAS REMOVED AND FOUND THE TIP HAD BROKEN OFF AND REMAINED IN THE PROSTATE. THE POWER SETTING WAS 80 WATTS. THE TIP WAS RETRIEVED WITH A GRASPER. NOTHING APPEARED WRONG, SO THEY CONTINUED THE CASE WITH ANOTHER FIBER. AT THE END OF THE CASE, THE DR NOTICED THAT WHEN HE PRESSED ON THE BLADDER, THE AREA WAS FIRM AND DISTENDED. THEY PERFORMED A CYSTOSCOPY AND IDENTIFIED A LASER BURN IN THE BLADDER WALL, APPROX 4 CM AWAY FROM THE RIGHT URETERAL ORIFICE AND FOUND FLUID LEAKING INTO THE PERITONEUM. THE DR WAS ABLE TO REMOVE FLUID FROM THE PERITONEUM. THE DR IDENTIFIED A "DIME" SIZED BURN ON THE OUTER BLADDER WALL THAT COINCIDED WITH THE SMALL BURN THEY SAW INTERNALLY. THERE WAS NO DAMAGE TO THE BOWEL, SECUM AND RECTUM. THE CLOSED THE HOLE IN THE BLADDER WALL WITH A DOUBLE LAYER CLOSE AND PERFORMED A SUCCESSFUL LEAK TEST. INVESTIGATION INCLUDED DIRECT CONTACT WITH THE DR WHO PERFORMED THE TREATMENT. A FEW DAYS AFTER THE INCIDENT AMS REP WHO HAD REPORTED THE INCIDENT, MET WITH THE HOSP STAFF INCLUDING THE THEATRE MGR, THE DIR OF NURSING AND TWO REPS FROM OLYMPUS. THE HOSP HAD LOANED TWO NEW OLYMPUS GREENLIGHT CYSTOSCOPE SET-UPS BUT WERE HAVING COMPATIBILITY ISSUES WITH THE FIBERS AND THEIR CAMERA SYSTEMS. THEY ELECTED TO USE THE SCOPES WITH A SUB-OPTIMAL CAMERA SYS AND CONSEQUENTLY VISIBILITY WAS RESTRICTED AND POOR DURING THE CASE. THE SURGEON AND STAFF WERE UNDER STRESS, AND THEY WERE TIRED AND IT WAS LATE IN THE EVENING. THE ISSUE HAS BEEN ATTRIBUTED TO HUMAN ERROR AND NO FURTHER ACTION OF AMS IS REQUIRED BY THE HOSP. THEY HAVE MADE THE DECISION TO HOLD OFF ON FURTHER SURGERIES UNTIL ADEQUATE EQUIPMENT CAN BE PURCHASED. THE MOST LIKELY CAUSE IS THAT WHILE LASING NEAR THE BLADDER NECK, THE DR EXTENDED THE FIBER AND FIRED INTO THE BLADDER. THE FIBER TIP AS OBSERVED BY AMS REP APPEARED HEAVILY CHARRED. THIS IS AN INDICATION OF TISSUE CONTACT. LABELING IS SUFFICIENT. OUR GREENLIGHT HPS BPH FIBER OPTIC PROD INSERT REV A, STATES: "IF EXCESSIVE TISSUE OR DEBRIS IS ALLOWED TO ACCUMULATE ON THE FIBER CAP, OVER HEATING OF THE FIBER CAP WILL OCCUR LEADING TO PREMATURE FIBER DEGRADATION AND/OR FIBER FAILURE." AND, "DO NOT BURY TIP IN TISSUE." AND, "IN THE UNLIKELY EVENT A DETACHED TIP, IT MAY BE VISUALLY LOCATED THROUGH AN APPROPRIATE SCOPE AND REMOVED USING FORCEPS. IRRIGATE THE AREA THOROUGHLY TO REMOVE ANY TRACES OF FIBER OR OTHER MATERIAL." OUR HPS PHYSICIAN'S TRAINING MANUAL, REV A, STATES: "MAINTAIN A WORKING DISTANCE OF 3 MM FROM TARGETED TISSUE." THE PT REMAINED IN THE HOSP THROUGH THE WEEKEND FOR OBSERVATION. ON AUGUST 11, 2008, THE FACILITY INDICATED TO OUR AMS REP THAT THE PT IS RECOVERING WELL AND A CYSTOGRAM HAS SHOWED NO ONGOING BLADDER ISSUES. NO FURTHER PROBLEMS HAVE BEEN REPORTED. NO CORRECTIVE ACTION IS REQUIRED BY AMS. THE HOSP WILL NOT PERFORM ANY FURTHER SURGERIES UNTIL ADEQUATE EQUIPMENT IS PURCHASED BY THEM. AMS HAS REQUESTED THE FIBER RETURN FOR EVAL. A F/U MEDWATCH REPORT WILL BE SENT WITH EVAL OF THE FIBER, IF THE FIBER IS RETURNED.

    Description of Event or Problem · 1

    DURING THE GREENLIGHT PVP (PHOTOSELECTIVE) PROCEDURE, THE DR PERFORMED A CYSTOSCOPY AND IDENTIFIED A LASER BURN IN THE BLADDER WALL AND WHAT APPEARED TO BE FLUID LEAKING INTO THE PERITONEUM. THE DR CLOSED THE HOLE IN THE BLADDER WALL AND PERFORMED A SUCCESSFUL LEAK TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT HPS LASER GEX AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER- SILICON VALLEY NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention