BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)

    MDR report key: 9652562 · Received January 31, 2020

    Report

    Report Number
    3005075853-2020-00635
    Event Type
    Injury
    Date Received
    January 31, 2020
    Report Date
    January 2, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT DATE: PUBLICATION YEAR OF 2007. BATCH # UNK. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DID THE PATIENT WHO EXPERIENCED SYMPTOMATIC URINOMA WITH ABDOMINAL PAIN AND FEVER UTILIZE HARMONIC SCALPEL?

    Description of Event or Problem · 1

    TITLE : LAPAROSCOPIC UPPER POLE PARTIAL. NEPHRECTOMY FOR DUPLICATED RENAL. COLLECTING SYSTEMS IN ADULT PATIENTS. AUTHOR : ROBERT ABOUASSALY, INDERBIR S. GILL, AND JIHAD H. KAOUK. CITATION: UROLOGY (2007); 69: 1202¿1205. DOI:10.1016/J.UROLOGY.2007.03.011. THE AUTHORS REPORTED THEIR EXPERIENCE WITH LAPAROSCOPIC UPPER POLE PARTIAL NEPHRECTOMY (LUPPN) IN ADULT PATIENTS WITH A DUPLICATED COLLECTING SYSTEM AND AN OBSTRUCTED, POORLY FUNCTIONING UPPER POLE RENAL MOIETY. THIS RETROSPECTIVE STUDY INVOLVES 5 PATIENTS (MEAN AGE: 45 YEARS; AGE RANGE: 21 TO 71 YEARS; BMI: 21 TO 27 KG/M2) WHO UNDERWENT LAPAROSCOPIC RESECTION OF UPPER POLE MOIETY FOR A DUPLICATED COLLECTING SYSTEM BETWEEN OCTOBER 2000 AND JUNE 2005. DURING THE PROCEDURE, THE RENAL UPPER POLE MOIETY WAS EXCISED ALONG THE ATROPHIC CLEAVAGE PLANE USING HARMONIC SCALPEL (ETHICON). REPORTED COMPLICATION INCLUDED SYMPTOMATIC URINOMA WITH ABDOMINAL PAIN AND FEVER (N-?) IN WHICH AN INTRA-ABDOMINAL DRAIN WAS PLACED. THE DRAINAGE GRADUALLY TAPERED OFF AND SYMPTOMS RESOLVED; THE DRAIN WAS REMOVED ON DAY 14 WITHOUT FURTHER COMPLICATION. THE FACT THAT THE RETROGRADE PYELOGRAM OF THE LOWER POLE WAS NORMAL SUGGESTS THAT THE URINE COLLECTION WAS CAUSED BY RESIDUAL UPPER POLE RENAL PARENCHYMA. IN CONCLUSION, THE LAPAROSCOPIC APPROACH TO PARTIAL NEPHRECTOMY FOR SYMPTOMATIC DUPLICATED SYSTEMS IN THE ADULT PATIENT IS SAFE AND EFFECTIVE AND OFFERS THE ADVANTAGE OF DECREASED MORBIDITY AND RAPID RECOVERY WITH AN EXCELLENT SUCCESS RATE, SIMILAR TO THAT WITH THE OPEN APPROACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118108 HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention