BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT PV

    MDR report key: 746469 · Received August 4, 2006

    Report

    Report Number
    2937094-2006-00009
    Event Type
    Injury
    Date Received
    August 4, 2006
    Report Date
    July 5, 2006
    Manufacturer
    LASERSCOPE
    Product Code
    GEX
    PMA / PMN Number
    K010284
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: SENIOR MEDICAL DEVICE SPECIALIST, MHRA HAS BEEN CORRESPONDING WITH LASERSCOPE'S INTERNATIONAL CLINICAL AFFAIRS MANAGER. THE CLINICAL AFFAIRS MANAGER HAS PROVIDED TO SR. MEDICAL DEVICE SPECIALIST, THE ANSWERS TO SPECIFIC QUESTIONS ABOUT THIS PARTICULAR LASER AND TRAINING PROGRAM DETAILS. FACILITY HAS REPORTED 2 PATIENTS WITH URETERIC OBSTRUCTION AFTER TREATMENT FOR BPH WITH THE GREENLIGHT LASER. ONE PATIENT WAS RE-ADMITTED TO THE HOSPITAL AFTER TREATMENT WITH LOIN PAIN, WHICH THEN REQUIRED ENDOSCOPIC ORIFICE RECONSTRUCTION WITH STENT PLACEMENT ON ONE SIDE. ANOTHER PATIENT REQUIRED ONE STENT AS WELL. LASERSCOPE BELIEVES THE INCIDENTS ARE VERY RARE AND ARE DIRECTLY RELATED TO TRAINING. THIS TYPE OF INCIDENT ONLY HAPPENS IF THE PHYSICIAN FIRES INTO THE BLADDER. THE TRAINING CLEARLY REQUESTS THAT THE PHYSICIAN IDENTIFY AND EXAMINE THE URETERS BEFORE AND AFTER THE CASE: THE GREENLIGHT PV PHYSICIAN TRAINING MANUAL, REV. F, CHAPTER 9, PAGE 52 & 53 STATE IN THE PROBLEM/CAUSE/SOLUTION CHART THE FOLLOWING: FOR PROBLEM: "PERSISTENCE OF BOTHERSOME SYMPTOMS"; CAUSE: "TRIGONE OR BLADDER FLOOR HAS BEEN LASED (IRRITATIVE SYMPTOMS)"; SOLUTION: "CAUTION WHEN LASING NEAR BLADDER NECK. PRIOR TO COMPLETION OF PROCEDURE, INSPECT BLADDER FLOOR AND TRIGONAL REGION FOR EVIDENCE INCIDENTAL LASING. IF INSPECTION REVEALS INCIDENTAL LASING, INSTITUTE APPROPRIATE PHARMACOLOGIC REGIME TO OBTAIN SYMPTOMATIC RELIEF..." FOR PROBLEM: "DYSURIA (PERSISTENT, SEVERE)"; CAUSE: "WORKING DISTANCE BETWEEN FIBER AND TISSUE TOO LARGE. RESULT: EXCESSIVE COAGULATION, EDEMA FORMATION AND DELAYED SLOUGHING. VLAP TECHNIQUE EMPLOYED. INCIDENTAL LASING OF TRIGONE"; SOLUTION: "IMPROVED FIBER HANDLING..., USE SWEEPING TECHNIQUE, CAREFUL VAPORIZATION OF MEDIAN AND LATERAL LOBES, ESPECIALLY NEAR BLADDER NECK. AVOID EXTENDING TIP OF LASER FIBER INTO BLADDER WHEN FIRING LASER NEAR BLADDER NECK." PATIENTS REQUIRED PLACEMENT OF STENT. PATIENTS ARE EXPECTED TO HAVE FULL RECOVERY. THE LASER WAS INSTALLED ON NOVEMBER 30, 2005 AND EVERYTHING WAS CHECKED BY LASERSCOPE'S SERVICE ENGINEERS AS WELL AS THE REQUIRED HOSPITAL'S MEDICAL PHYSICS DEPARTMENT. NO MALFUNCTION OF THE LASER HAS BEEN REPORTED. LABELING IS SUFFICIENT. NO CORRECTIVE ACTION IS NECESSARY. IF ANY FURTHER INFORMATION IS OBTAINED, A FOLLOW UP MEDWATCH REPORT WILL BE SENT.

    Description of Event or Problem · 1

    FACILITY HAS REPORTED 2 PATIENTS WITH URETERIC OBSTRUCTION AFTER TREATMENT FOR BPH WITH THE GREENLIGHT PV LASER. ONE PATIENT WAS RE-ADMITTED TO THE HOSPITAL AFTER TREATMENT WITH LOIN PAIN, WHICH THEN REQUIRED ENDOSCOPIC ORIFICE RECONSTRUCTION WITH STENT PLACEMENT ON ONE SIDE. ANOTHER PATIENT REQUIRED ONE STENT AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT PV LASER GEX LASERSCOPE NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other