BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)

    MDR report key: 9356512 · Received November 21, 2019

    Report

    Report Number
    3005075853-2019-23664
    Event Type
    Injury
    Date Received
    November 21, 2019
    Report Date
    October 24, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS EVALUATION COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    TITLE: LAPAROSCOPIC UPPER POLE HEMINEPHRECTOMY IN ADULTS FOR TREATMENT OF DU­PLEX KIDNEYS. AUTHOR/S: MUHAMMET IRFAN DONMEZ, MUSTAFA SERTAC, YAZICI, DENIZ ABAT, ÖNDER KARA, YILDIRIM BAYAZIT, CENK YÜCEL BILEN CITATION: LAPAROSCOPIC UROLOGY (2015); 12(02): 2074-2077. THE AIM OF THIS STUDY IS TO PRESENT THE RESULTS OF LAPAROSCOPIC UPPER POLE HEMINEPHRECTOMY IN ADULT PATIENTS WITH DUPLEX KIDNEY. THIS RETROSPECTIVE REVIEW INVOLVES A TOTAL OF 10 PATIENTS (4 MALE AND 6 FEMALE; AGE RANGE: 27 TO 54 YEARS OLD) WHO UNDERWENT LAPAROSCOPIC UPPER POLE HEMINEPHRECTOMY FOR COMPLETE DUPLICATION OF THE RENAL COLLECTING SYSTEM BETWEEN APRIL 2005 AND MARCH 2010. AFTER MOVING THE COLON MEDIALLY, THE KIDNEY AND THE DUPLICATED URETERS WERE IDENTIFIED WITH BLUNT AND SHARP DISSECTION. THE NORMAL LOWER POLE URETER WAS IDENTIFIED AND WAS PRECISELY DISSECT IT AWAY FROM THE EFFECTED UPPER POLE URETER USING HARMONIC SCALPEL (ETHICON). THEN, THE UPPER POLE URETER WAS FULLY MOBILIZED AWAY FROM THE RENAL HILUM (POSTERIOR AND CEPHALAD). DURING DISSECTION, THE ARTERY AND VEIN SUPPLYING THE UPPER POLE WERE PRECISELY IDENTIFIED AND LIGATED. AFTER TRANSECTION OF THE URETER AND ITS TRANSPOSITION CEPHALAD TO THE HILUM, DISSECTION OF THE UPPER POLE MOIETY WAS PERFORMED USING HARMONIC SCALPEL (ETHICON) THROUGH THE DEMARCATION LINE. REPORTED COMPLICATION INCLUDED: PATIENT 7, A 42 YEAR OLD FEMALE PATIENT WITH LOWER POLE PERFORATION AND WAS SUTURED INTRACORPOREALLY. PATIENT 9, A 28 YEAR OLD MALE PATIENT WITH MINIMAL URINARY EXTRAVASATION FROM THE NORMAL URETER WHICH WAS THOUGHT TO BE INJURED DURING DISSECTION AND WAS SUCCESSFULLY MANAGED WITH AN INTERNAL STENT (DOUBLE J URETERAL STENT) INSERTION, THE PATIENT WAS DISCHARGED THE OTHER DAY. IN CONCLUSION, LAPAROSCOPIC UPPER POLE HEMINEPHRECTOMY FOR AN ECTOPIC URETER IS SAFE AND REPRODUCIBLE AND OFFERS BENEFITS OF LAPAROSCOPIC SURGERY EVEN IN PATIENTS WITH COMPLICATED URINARY TRACT INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1153937 HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other