BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 9382755 · Received November 27, 2019

    Report

    Report Number
    2210968-2019-90203
    Event Type
    Injury
    Date Received
    November 27, 2019
    Report Date
    November 7, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS BEEN PROVIDED. 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT THE ETHICON PRODUCT (PROLENE SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POSTOPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON (PROLENE) SUTURE PRODUCTS USED IN THIS PROCEDURE? SPECIFIC NUMBER OF PATIENTS IN THE INITIAL PHASE GROUP , INTERMEDIATE PHASE GROUP AND ADVANCED PHASE GROUP WHO EXPERIENCED PAIN. CITATION: SURGICAL LAPAROSCOPY, ENDOSCOPY & PERCUTANEOUS TECHNIQUES (2016); 26:P 364-367. DOI: 10.1097/SLE.0000000000000309. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE" TITLE : THE LEARNING CURVE OF TRANSAREOLA SINGLE-SITE LAPAROENDOSCOPIC THYROIDECTOMY: CUSUM ANALYSIS OF A SINGLE SURGEON'S EXPERIENCE." AUTHOR : ZHU, GUANGHUI MD; ZHANG, XUELI MD; TANG, ZHIQIANG MD; TAN, ZHANHAI MD; CHEN, JIANRONG MD; SHAN, YUANZHOU MD. CITATION: SURGICAL LAPAROSCOPY, ENDOSCOPY & PERCUTANEOUS TECHNIQUES (2016); 26:P 364-367. DOI: 10.1097/SLE.0000000000000309. THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE LEARNING CURVE FOR TRANSAREOLA SINGLE-SITE LAPAROENDOSCOPIC THYROIDECTOMY (TASSET). THIS STUDY INCLUDED 45 CONSECUTIVE PATIENTS UNDERGOING THYROID NODULE SURGERY BETWEEN JANUARY 2011 AND MARCH 2014. DATA FROM ALL PATIENTS WHO UNDERWENT A THYROIDECTOMY WERE PROSPECTIVELY RECORDED. PATIENTS WERE CHRONOLOGICALLY ARRANGED INTO 3 PHASES FOR THE CUMULATIVE SUMMATION ANALYSIS, MEANING THAT PATIENTS WERE CONSECUTIVELY ASSIGNED TO A GROUP CORRESPONDING TO THEIR OPERATIVE ORDER. THIS PROCEDURE WAS DIVIDED INTO: INITIAL GROUP (GROUP 1) WITH 15 PATIENTS (2 MALE AND 13 FEMALE; AGE: 27.21±9.25 YEARS) , INTERMEDIATE GROUP (GROUP 2) WITH 15 PATIENTS (1 MALE AND 14 FEMALE; AGE: 28.67±7.92 YEARS), AND ADVANCED PHASES GROUP (GROUP 3) WITH 15 PATIENTS (1 MALE AND 14 FEMALE; AGE:28.70±8.90 YEARS). THE TASSET PROCEDURE WAS CHARACTERIZED BY A 20-MM INCISION DELINEATED ALONG THE IPSILATERAL AREOLA MARGIN OF THE LESION SIDE. A SPACE BETWEEN THE PLATYSMA AND STRAP MUSCLES WAS CREATED WITH ULTRASONIC SHEARS (HARMONIC SCALPEL; ETHICON). AFTER LONGITUDINALLY INCISING THE MEDIAL BORDER OF THE STERNOHYOID AND STERNOTHYROID MUSCLES, THE IPSILATERAL STRAP MUSCLES WERE SUSPENDED ANTERIORLY AND LATERALLY WITH TRANSCUTANEOUS PROLENE SUTURES (ETHICON). AFTER THE ISTHMUS WAS DIVIDED, THE LOWER LOBE OF THE THYROID GLAND WAS DRAWN UPWARD AND BLUNTLY DISSECTED. THE INFERIOR PARATHYROID GLAND WAS IDENTIFIED AND CAREFULLY PRESERVED, WITH INTACT BLOOD SUPPLY. THE SUPERIOR THYROID VESSELS WERE IDENTIFIED AND DISSECTED CLOSE TO THE THYROID GLAND TO AVOID INJURING THE SUPERIOR LARYNGEAL NERVE. THE RECURRENT LARYNGEAL NERVE WAS TRACED AND DISSECTED WITH GREAT CARE DURING THE COMPLETE LOBECTOMY PROCEDURE. REPORTED COMPLICATION IN THE INITIAL PHASE GROUP INCLUDED PAIN VAS SCALE (N-?) AND SUBCUTANEOUS SEROMA (N-1). REPORTED COMPLICATION IN THE INTERMEDIATE PHASE GROUP INCLUDED PAIN VAS SCALE (N-?). REPORTED COMPLICATION IN THE ADVANCED PHASE GROUP INCLUDED PAIN VAS SCALE (N-?), SUBCUTANEOUS SEROMA (N-1) AND TRANSIENT RECURRENT LARYNGEAL NERVE PALSY (N-1). OTHER COMPLICATION INCLUDED: TRACHEAL INJURY (N-1). IN CONCLUSION, THE TASSET METHOD ENABLES THE SAFE HANDLING OF SURGICAL INSTRUMENTS, RESULTING IN A REDUCTION IN OPERATIVE TIME, BLOOD LOSS, AND POSTOPERATIVE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180224 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention