BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VCL CT BRD UD 36IN 0 S/A CTX

    MDR report key: 9245846 · Received October 28, 2019

    Report

    Report Number
    2210968-2019-89139
    Event Type
    Injury
    Date Received
    October 28, 2019
    Date of Event
    September 27, 2019
    Report Date
    September 30, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031043800
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). IT WAS REPORTED THAT DURING C-SECTION IN WHICH THE TIP OF SUTURE NEEDLE BROKE OFF WHILE SUTURING THE UTERUS. THE PATIENT RECEIVED THREE X-RAYS, TRYING TO LOCATE THE BROKEN NEEDLE TIP. ON THE FIRST X-RAY, IT WAS LOCATED, ON THE SECOND X-RAY, IT MOVED AND ON THE THIRD X-RAY, IT COULDN'T BE LOCATED. UNKNOWN WHERE THE TIP IS, NOW. PATIENT'S UTERUS WAS OUTSIDE THE BODY FOR FIVE HOURS. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. 2 SURGEONS WERE INVOLVED DURING THE PROCEDURE TO ASSIST WITH LOCATING THE NEEDLE. NO ADDITIONAL INFORMATION IS AVAILABLE. ADDITIONAL EVENT AS REPORTED IN MW# 5090158,: PER HEALTHCARE PROFESSIONAL DURING SUTURING POST C-SECTION , SURGEON DISCOVERED THE TIP OF THE 0 VICRYL CTX NEEDLE WAS MISSING. INITIAL X-RAY SHOWED THAT THE NEEDLE TIP WAS IN FACT IN THE PATIENT, BUT NOT CLEAR EXACTLY WHERE. TOWELS COVERING THE EXPOSED UTERUS WERE FLUSHED THE SALINE INTO A BASIN AND STRAINED OUT INTO A BASIN TO CHECK ANY METAL PARTS, BUT NOTHING WAS FOUND. A REPEAT X-RAY WAS DONE AND A MAGNET WAS USED IN ATTEMPTS TO LOCATE THE TIP, BUT THE TIP WAS NEVER LOCATED. A SECOND SURGEON WAS CALLED INTO THE OPERATING ROOM FOR CONSULT, AND IT WAS RECOMMENDED AFTER 3RD ROUND OF X-RAYS TO CLOSE THE PATIENT IN ORDER TO PREVENT ANY DAMAGE TO PROLONGED EXPOSURE OF THE UTERUS. THE NEEDLE TIP WAS NO LONGER VISIBLE ON THE 3RD X-RAY. THIS MEDWATCH REPORT IS IN RESPONSE TO RECEIPT OF MAUDE EVENT REPORT MW# 5090158.

    Additional Manufacturer Narrative · 1

    (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. DEVICE EVALUATION SUMMARY: A SUTURE NEEDLE WAS SUBMITTED FOR EVALUATION. A FRACTURE WAS OBSERVED AT THE TIP OF THE NEEDLE. ONE SIDE OF THE NEEDLE WAS RECEIVED, THE MATING FRACTURE SURFACE WAS NOT PROVIDED 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 IN ORDER TO DETERMINE THE FRACTURE MODE. THE EVALUATION REVEALED THE FRACTURE WAS COMPOSED OF MICROVOID COALESCENCE, WHICH IS EVIDENCE OF A DUCTILE OVERLOAD FAILURE. MECHANICAL DAMAGE OBSERVED COINCIDENTAL TO THE FRACTURE PROVIDES ADDITIONAL EVIDENCE THAT THE FAILURE WAS INDUCED BY MECHANICAL DEFORMATION LEADING TO DUCTILE OVERLOAD. THIS WAS A DUCTILE FRACTURE. THE MANUFACTURING RECORDS WERE REVIEWED, AND THE MANUFACTURING/ PACKAGING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS BATCH. THE EVIDENCE OF THIS EXAMINATION INDICATES THAT THE BREAKAGE OCCURRED AT THE TIP OF THE NEEDLE DURING USE DUE TO TENSILE OVERLOAD. THERE IS NO EVIDENCE OF ANY MATERIAL FLAW OR DEFECT THAT WOULD CAUSE PREMATURE FAILURE. IN ORDER TO AVOID THIS KIND OF DAMAGE GRASP THE NEEDLE IN AN AREA ONE-THIRD (1/3) TO ONE-HALF (1/2) OF THE DISTANCE FROM THE ATTACHMENT END TO THE POINT. THE NEEDLE BREAKAGE WAS CONFIRMED. 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. THE PATIENT DEMOGRAPHIC INFO: WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE CAN YOU CONFIRM THE DATE OF THE INITIAL PROCEDURE WAS 9/27 WITH DR. LEENHOUTS? WHAT WAS THE TISSUE CONDITION, I.E., NORMAL OR THIN, CALCIFIED, FRAGILE, DISEASED? WHAT INSTRUMENTS WERE USED TO GRASP THE NEEDLE? WHERE WAS THE NEEDLE GRASPED DURING USE? WHERE WAS THE NEEDLE FRAGMENT LOCATED, IN WHAT TISSUE/STRUCTURE? WHAT PORTION OF THE NEEDLE TIP WAS RETAINED IN THE PATIENT (IN CM)? DOES THE NEEDLE FRAGMENT REMAIN RETAINED IN THE PATIENT? WERE ALL NEEDLE FRAGMENTS REMOVED DURING THE INITIAL PROCEDURE? WAS THERE ANY CHANGE TO THE PATIENTS POST OPERATIVE CARE DUE TO THE EXTENDED PROCEDURE? WILL THE DEVICE INVOLVED IN THE EVENT BE RETURNING FOR EVALUATION? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT¿S CURRENT STATUS?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE TIP OF THE NEEDLE CAME OFF AND FELL INTO THE PATIENT. X-RAY CONFIRMED THE FRAGMENT. AFTER THREE ATTEMPTS TO RETRIEVE THE FRAGMENT THEY COULD NO LONGER LOCATE IT AND HAD TO ABORT. THE PATIENT'S UTERUS WAS OUT OF CAVITY FOR FIVE HOURS. THE PATIENT APPEARS TO BE FINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040480 VCL CT BRD UD 36IN 0 S/A CTX SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. MKZ597 10705031043800

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention