BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDSII VIO 27IN USP5-0

    MDR report key: 21872676 · Received April 21, 2025

    Report

    Report Number
    2210968-2025-04258
    Event Type
    Injury
    Date Received
    April 21, 2025
    Date of Event
    March 31, 2025
    Report Date
    May 7, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    UDI-DI
    10705031113237
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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 INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC 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 INFORMATION: D9, H3, H6. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: NAME OF INDEX SURGICAL PROCEDURE? THE PATIENT WAS HOSPITALIZED IN THE UROLOGICAL SURGERY DEPARTMENT HC FOR THE TREATMENT OF A RIGHT PYELOURETERAL JUNCTION SYNDROME UNDER ROBOTIC-ASSISTED LAPAROSCOPIC SURGERY. ON WHAT TISSUE WAS THE SUTURE USED? AT THE LEVEL OF THE URETERS (TISSUES: MUSCLE MUCOSA). WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? HOW WAS THE SUTURE PLACED (INTERRUPTED OR CONTINUOUS)? WHAT INSTRUMENTS WERE USED TO GRASP THE NEEDLE? WHERE WAS THE NEEDLE GRASPED DURING USE? THE NEEDLE WAS GRASPED AT ITS TIP. WHAT WAS THE SIZE OF THE NEEDLE USED? IT IS A 3/8 CIRCLE NEEDLE (5-0). OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? NO CONCOMITANT MEDICATION TREATMENT. WHAT IS THE PATIENT'S CURRENT STATUS? THE PATIENT WAS DISCHARGED FROM THE OPERATION UNDER LEVEL 2 ANALGESICS FOR POST-OPERATIVE PAIN (FOLLOW-UP APPOINTMENT SOON FOR THE REMOVAL OF THE DOUBLE J STENT). CONSEQUENCES FOR THE PATIENT: ADDITIONAL STITCHES, ADDITIONAL PAIN, NEW GENERAL ANESTHESIA. ADDITIONAL H3 INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. ONE NEEDLE INSIDE THE PETRI DISH WAS RECEIVED FOR ANALYSIS. PRODUCT CODE Z1043H. DURING THE VISUAL INSPECTION OF THE NEEDLE, MARKS PROBABLY CAUSED BY A SURGICAL INSTRUMENT WERE NOTED AT THE EDGE OF THE SWAGE AREA. IN ADDITION, IT WAS NOTICED THAT THERE WERE REMNANTS OF THE SUTURE IN THE BARREL HOLE. THE SUTURE WAS NOT RETURNED FOR ANALYSIS. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS OF THIS LOT-SERIAL NUMBER WERE REVIEWED, AND THE MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS BATCH. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. 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. H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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. PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE NAME OF INDEX SURGICAL PROCEDURE? ON WHAT TISSUE WAS THE SUTURE USED? WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? HOW WAS THE SUTURE PLACED (INTERRUPTED OR CONTINUOUS)? WHAT INSTRUMENTS WERE USED TO GRASP THE NEEDLE? WHERE WAS THE NEEDLE GRASPED DURING USE? WHAT WAS THE SIZE OF THE NEEDLE USED? OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT'S CURRENT STATUS? WILL PRODUCT BE RETURNED? IF SO, PLEASE PROVIDE THE RETURN DATE AND TRACKING INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE FOR RIGHT PYELOURETERAL JUNCTION SYNDROME ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE ROBOTIC PROCEDURE, AT THE TIME OF KNOT OF THE SUTURE (FIRST PASSAGE OF THE NEEDLE) LOSS OF THE NEEDLE IN THE ABDOMINAL CAVITY OF THE PATIENT. FIRST SEARCH WAS DONE IN THE PATIENT'S TUMMY WITH AN OPTICAL IMAGE INTENSIFIER AND THEN ON THE FLOOR FOR MORE THAN ONE HOUR, WITHOUT ANY RESULTS. THE PATIENT UNDERWENT ANOTHER FLUOROSCOPY WHICH WAS PERFORMED IN THE RECOVERY ROOM AT THE INITIATIVE OF THE SURGEON FOR OBSERVATION OF THE NEEDLE IMAGING. THE PATIENT REQUIRED AN IMMEDIATE POSTOPERATIVE SECOND LAPAROSCOPY TO REPEATEDLY REMOVE THE NEEDLE. THE PATIENT HAS BEEN WITHOUT COMPLICATIONS TO DATE. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1275218 PDSII VIO 27IN USP5-0 SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE NEW ETHICON INC. QJMAAQ 10705031113237

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention