BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCL CT BRD VIO 27IN 1 S/A CT-1

    MDR report key: 11077580 · Received December 28, 2020

    Report

    Report Number
    2210968-2020-10326
    Event Type
    Malfunction
    Date Received
    December 28, 2020
    Date of Event
    December 7, 2020
    Report Date
    December 9, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031039056
    PMA / PMN Number
    K022269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 2/12/2021. 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER QAMCKQ /J341W05, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. ADDITIONAL H3 INVESTIGATION SUMMARY: A SUTURE NEEDLE WAS RETURNED FOR EVALUATION. A FRACTURE WAS OBSERVED IN THE BODY OF THE NEEDLE. THE NEEDLE WAS RECEIVED IN TWO PIECES, ONLY ONE OF THE MATING FRACTURE SURFACES WAS EXAMINED FOR THIS EVALUATION. A SCANNING ELECTRON MICROSCOPE (SEM) WAS USED TO EXAMINE THE FRACTURE SURFACES AND SURROUNDING AREA OF THE NEEDLE. THE FRACTURE SURFACES WERE EXAMINED IN MULTIPLE LOCATIONS TO DETERMINE THE FRACTURE MODE. THE FRACTURE SURFACE CONTAINED MICROVOID COALESCENCE (MVC), EVIDENCE OF A DUCTILE FRACTURE MODE. MECHANICAL DAMAGE, A CUP-AND-CONE SHAPED FRACTURE AND MACROSCOPIC PLASTIC DEFORMATION OBSERVED COINCIDENTAL TO THE FRACTURE PROVIDE ADDITIONAL EVIDENCE THAT THE FAILURE WAS INDUCED BY MECHANICAL DEFORMATION LEADING TO DUCTILE OVERLOAD. THIS WAS A DUCTILE FRACTURE. 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. THE EVIDENCE OF THIS EXAMINATION INDICATES THAT THE BREAKAGE OCCURRED FROM MECHANICAL DEFORMATION, INDENTS AND SCRATCHES, DUE TO GRIPPING, BENDING AND OVERSTRESSING OF THE NEEDLE. THERE IS NO EVIDENCE OF ANY MATERIAL FLAW THAT WOULD CAUSE PREMATURE FAILURE.

    Additional Manufacturer Narrative · 1

    PC (B)(4). 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. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: COULD YOU PLEASE CONFIRM WHAT WAS THE EXACT ISSUE? =>THE NEEDLE WAS BROKEN AT THE BODY PART WHEN PUTTING THE 1ST STITCH ON THE MUSCLE LAYER. DID THE NEEDLE BROKE OR DID THE SUTURE AND THE NEEDLE GOT SEPARATED? PLEASE SPECIFY : THE NEEDLE BROKE. WHAT DO YOU MEAN BY "" THE NEEDLE WAS BROKEN AT THE BODY PART (TO THE SWAGE PART?)""? : ACCORDING TO THE SALES REP, WHEN HE CHECKED THE BROKEN NEEDLE WITH THE NAKED EYE, THE BROKEN POSITION SEEMED TO BE THE MIDDLE PART OF THE NEEDLE. HOWEVER, HE ALSO MENTIONED THAT IT MIGHT HAVE BEEN THE SWAGE PART. (IT IS SUPPOSED THAT THE NEEDLE BROKE AT THE BODY PART NEAR THE SWAGE PART (OR AT THE SWAGE PART.) DEVICE RETURN FOLLOW UP. : WE REGULARLY CONTACT WITH SALES REP ABOUT THE DEVICE RETURNING. NO FURTHER INFORMATION WILL BE PROVIDED. 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 · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOT-ASSISTED TOTAL PROSTATECTOMY ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE FIXATION OF THE CAMERA PORT WITH THE NEEDLE-SUTURE, WHEN PUTTING THE 1ST STITCH ON THE MUSCLE LAYER, THE NEEDLE WAS BROKEN AT THE BODY PART. NO PIECES FELL INTO THE PATIENT. THE BROKEN NEEDLE PIECE HAS BEEN RETRIEVED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1542711 VCL CT BRD VIO 27IN 1 S/A CT-1 SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. J341H QAMCKQ 10705031039056

    Patients

    Seq Age Sex Outcome Treatment
    1