BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN UNKNOWN PRODUCT

    MDR report key: 19865102 · Received July 30, 2024

    Report

    Report Number
    2210968-2024-07849
    Event Type
    Injury
    Date Received
    July 30, 2024
    Date of Event
    March 23, 2023
    Report Date
    August 21, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GBX
    PMA / PMN Number
    CL I EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. NO FURTHER INFORMATION WILL BE PROVIDED BECAUSE WE CAN¿T GET ANY ADDITIONAL INFORMATION FROM THE AUTHOR. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION: H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NOT RECEIVED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED (BLAKE DRAIN UNKNOWN) CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS: SURGICAL SITE INFECTION, DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? PATIENT DEMOGRAPHICS? THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. NO PRODUCT AVAILABLE FOR RETURN. CITATION: INTERNATIONAL JOURNAL OF UROLOGY (2023) 30, 579--584 DOI: 10.1111/IJU.15182 JOURNAL ARTICLE ATTACHED. AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    TITLE: NECESSITY OF PROPHYLACTIC DRAINAGE TUBE IN RETROPERITONEAL LAPAROSCOPIC NEPHROURETERECTOMY WITH OPEN DISTAL URETERECTOMY: A MATCHED-PAIR ANALYSIS THE OBJECTIVE OF THE STUDY IS TO ASSESS THE NECESSITY OF PROPHYLACTIC DRAIN PLACEMENT IN RETROPERITONEAL LAPAROSCOPIC NEPHROURETERECTOMY WITH OPEN DISTAL URETERECTOMY FOR UPPER TRACT UROTHELIAL CANCER. BETWEEN JULY 2011 AND MARCH 2021, 164 PATIENTS WITH LOCALIZED CLINICAL TIS-T3 UPPER URINARY TRACT UROTHELIAL CARCINOMA WHO UNDERWENT LAPAROSCOPIC NEPHROURETERECTOMY WITH OPEN DISTAL URETERECTOMY WERE INCLUDED IN THE STUDY. AFTER REMOVING THE SPECIMEN, DRAINAGE TUBES WERE PLACED ON THE RENAL BEDS AND/OR IN THE RETROVESICAL SPACES. DRAIN TUBES WERE OMITTED FOR MOST PATIENTS AFTER 2017. IN THIS STUDY, 90 PATIENTS (MEDIAN AGE :75 YEARS, 65 MALES, MEDIAN BMI: 22.9 KG/M2) HAD DRAIN PLACEMENT (D+ GROUP) AND WHILE 74 PATIENTS (MEDIAN AGE :77 YEARS, 44 MALES, MEDIAN BMI: 22.4 KG/M2) HAD NO DRAIN PLACEMENT (D-GROUP). DURING THE PROCEDURE, RENAL ARTERIES AND VEINS WERE CUT AFTER LIGATING USING A NON-ETHICON HEM-O-LOK (MANUFACTURER: TELEFLEX). THE KIDNEY AND PROXIMAL URETER SPECIMENS WERE WRAPPED AND SEMI-CLOSED IN A NON-ETHICON RUSCH MEMOBAG (MANUFACTURER: TELEFLEX). IN THE D+ GROUP, A 19FR BREAK-TYPE DRAIN (J-VAC, ETHICON) WAS PLACED ON THE RENAL BED AND/OR IN THE RETROVESICAL CAVITY AFTER SURGERY; THE DURATION OF DRAIN PLACEMENT WAS DETERMINED BY THE ATTENDING PHYSICIAN ACCORDING TO THE AMOUNT AND NATURE OF DRAINAGE. ALL PATIENTS ACCEPTED COMPUTE TOMOGRAPHY FOR POSTOPERATIVE FOLLOW-UP ROUTINELY WITHIN 3 MONTHS. REPORTED COMPLICATIONS INCLUDED PERIOPERATIVE INFECTION (N=4). IN CONCLUSION, WE FOUND THAT OMITTING THE DRAINAGE TUBE AFTER LAPAROSCOPIC RADICAL NEPHROURETERECTOMY DID NOT INCREASE POSTOPERATIVE COMPLICATIONS OR LYMPHOCELE AND SHORTENED THE POST-HOSPITAL STAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208303 BLAKE DRAIN UNKNOWN PRODUCT CATHETER, IRRIGATION GBX ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other