BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIT, CRYOSURGICAL, ACCESSORIES

    MDR report key: 10117218 · Received June 3, 2020

    Report

    Report Number
    2134265-2020-07475
    Event Type
    Injury
    Date Received
    June 3, 2020
    Date of Event
    January 1, 2020
    Report Date
    September 29, 2020
    Manufacturer
    GALIL MEDICAL LTD.
    Product Code
    GEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION IS CORRECTED IN THIS REPORT: D2/H10: ADDITIONAL PRO CODE OCL IS NOT APPLICABLE. THE REPORTED RECTAL FISTULA, URETHRAL FISTULA AND PULMONARY EMBOLISM ARE ALL LISTED AS POTENTIAL ADVERSE EVENTS WITHIN THE DEVICE LABELLING, AND ARE THUS ANTICIPATED IN THEIR NATURE AND SEVERITY. THE REPORTED ADVERSE EVENTS ARE KNOWN INHERENT RISKS OF THE DEVICE. THIS COMPLAINT IS DEIVED FROM THE LITERATURE ARTICLE TITLED: "SAFAVY, S., JABAJI, R. B., LU, S. M., SLEZAK, J. M., COSMATOS, H. A., WILLIAMS, S. G., & FINLEY, D. S. (2019). SALVAGE CRYOABLATION FOR RADIORECURRENT PROSTATE CANCER: INITIAL EXPERIENCE AT A REGIONAL HEALTH CARE SYSTEM. THE PERMANENTE JOURNAL." PERM J 2019;23:18 TO 153, HTTPS://DOI.ORG/10.7812/TPP/18-153 PUBLICATION DATE: JAN 2020 - DEFAULT TO FIRST DAY OF THE MONTH, 01 JAN 2020.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE THAT DURING A PROSTATE CRYOABLATION PROCEDURE, PATIENTS EXPERIENCED COMPLICATIONS OF URETHRAL STRICTURE AND RECTAL FISTULA. THE PUBLISHED LITERATURE ARTICLE: "SAVAGE CRYOABLATION FOR RADIORECURRENT PROSTATE CANCER: INITIAL EXPERIENCE AT A REGIONAL HEALTH CARE SYSTEM" BY SAFAVY. ET AL. 2019 IS A RETROSPECTIVE, SINGLE-CENTRE REVIEW OF 75 PATIENTS WHO RECEIVED CRYOABLATION TREATMENT FOR PROSTATE CANCER WITH EITHER GALIL (GALIL MEDICAL) OR ENDOCARE (ENDOCARE/HEALTHTRONICS INC). THE FOLLOWING COMPLICATIONS WERE REPORTED: 2 RECTAL FISTULAES, (2.7%), 5 URETHRAL STRICTURES (6.7%), 19 PATIENTS WITH STRESS URINARY INCONTINENCE REQUIRING AT LEAST 1 PAD PER DAY (25.3%), AND 1 DEATH CAUSED BY PULMONARY EMBOLISM (1.3%). NO DEVICE MALFUNCTIONS WERE REPORTED IN THE ARTICLE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRO CODE: OCL. THIS COMPLAINT IS DERIVED FROM THE LITERATURE ARTICLE TITLED: "SAFAVY, S., JABAJI, R. B., LU, S. M., SLEZAK, J. M., COSMATOS, H. A., WILLIAMS, S. G., & FINLEY, D. S. (2019). SALVAGE CRYOABLATION FOR RADIO RECURRENT PROSTATE CANCER: INITIAL EXPERIENCE AT A REGIONAL HEALTH CARE SYSTEM. THE PERMANENTE JOURNAL." PERM J 2019;23:18 TO 153, HTTPS://DOI.ORG/10.7812/TPP/18-153 PUBLICATION DATE: JAN 2020 - DEFAULT TO FIRST DAY OF THE MONTH, 01 JAN 2020.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE THAT DURING A PROSTATE CRYOABLATION PROCEDURE, PATIENTS EXPERIENCED COMPLICATIONS OF URETHRAL STRICTURE AND RECTAL FISTULA. THE PUBLISHED LITERATURE ARTICLE: "SALVAGE CRYOABLATION FOR RADIO RECURRENT PROSTATE CANCER: INITIAL EXPERIENCE AT A REGIONAL HEALTH CARE SYSTEM" BY SAFAVY. ET AL. 2019 IS A RETROSPECTIVE, SINGLE-CENTRE REVIEW OF 75 PATIENTS WHO RECEIVED CRYOABLATION TREATMENT FOR PROSTATE CANCER WITH EITHER GALIL (GALIL MEDICAL) OR ENDOCARE (ENDOCARE/HEALTHTRONICS INC). THE FOLLOWING COMPLICATIONS WERE REPORTED: 2 RECTAL FISTULAS, (2.7%), 5 URETHRAL STRICTURES (6.7%), 19 PATIENTS WITH STRESS URINARY INCONTINENCE REQUIRING AT LEAST 1 PAD PER DAY (25.3%), AND 1 DEATH CAUSED BY A PULMONARY EMBOLISM (1.3%). NO DEVICE MALFUNCTIONS WERE REPORTED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581052 UNIT, CRYOSURGICAL, ACCESSORIES GEH GALIL MEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention