BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 9402949 · Received December 3, 2019

    Report

    Report Number
    2210968-2019-90441
    Event Type
    Injury
    Date Received
    December 3, 2019
    Report Date
    November 13, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    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 NOT BEEN PROVIDED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL PATIENT EVENTS. 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 ETHICON PRODUCTS (PROLENE SUTURE, PDS SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (PROLENE SUTURE, PDS SUTURE) USED IN THIS PROCEDURE? PATIENT DEMOGRAPHICS: CITATION: J GASTROINTEST SURG. 2017; 21: 321¿329. DOI: 10.1007/S11605-016-3312-Y. EVENT RELATED TO LIVER GRAFT, VESSEL ANASTOMOSIS SUTURE CAPTURED IN MW 2210968-2019-90438.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE: SPRAY DIATHERMY VERSUSHARMONIC SCALPEL TECHNIQUE FOR HEPATIC PARENCHYMAL TRANSECTION OF LIVING DONOR" AUTHORS: MOHAMED EL SHOBARY, TAREK SALAH, AYMAN EL NAKEEB, AHMAD M. SULTAN, AHMED ELGHAWALBY, OMAR FATHY, MOHAMED ABDEL WAHAB, AMRO YASSEN, MOHAMED ELMORSHEDY, WAGDI F. ELKASHEF, USAMA SHIHA, MOHAMED ELSADANY CITATION: J GASTROINTEST SURG. 2017; 21: 321¿329. DOI: 10.1007/S11605-016-3312-Y. LIVER PARENCHYMAL TRANSECTION IS THE MOST INVASIVE AND CHALLENGING PART IN THE LIVING DONOR OPERATION. THE STUDY WAS PLANNED TO COMPARE THE SAFETY, EFFICACY, AND OUTCOME OF HARMONIC SCALPEL VERSUS SPRAY DIATHERMY AS A METHOD OF PARENCHYMAL LIVER TRANSECTION IN DONOR HEPATECTOMY. A TOTAL OF 80 CONSECUTIVE PATIENTS, WHO WERE TREATED BY LIVING DONOR LIVER TRANSPLANTATION (LDLT), WERE INCLUDED IN THE STUDY. THE STUDY POPULATION WAS DIVIDED INTO TWO GROUPS ACCORDING TO THE METHOD OF LIVER TRANSECTION: GROUP A BY HARMONIC SCALPEL (ETHICON; AGE RANGE: 18 TO 45 YEARS OLD; 25 MALE AND 15 FEMALE PATIENTS; BMI: 20 TO 31) AND GROUP B BY SPRAY DIATHERMY (SD; AGE RANGE: 16 TO 53 YEARS OLD; 28 MALE AND 12 FEMALE PATIENTS; BMI: 20 TO 36). FOR THE DONOR SURGERY DURING THE PARENCHYMAL LIVER TRANSECTION THAT WAS CARRIED OUT IN GROUP A, THE AUTHORS USED HARMONIC SCALPEL (ETHICON). IN BOTH GROUPS, THE CLEARLY EXPOSED VESSELS WERE SUTURED BY PROLENE 4-0 OR 5-0 (ETHICON) ACCORDING TO THEIR SIZE. IN BOTH GROUPS, WHEN THE LIVER GRAFT IS TRANSPLANTED TO THE RECIPIENT. THE RHV OF THE PATIENT AND THE LIVER GRAFT WERE ANASTOMOSED END TO END BY PROLENE 4-0 SUTURES (ETHICON), PORTAL VEIN RECONSTRUCTION WAS DONE USING PROLENE 6-0 (ETHICON). HEPATIC ARTERY RECONSTRUCTION WAS CARRIED OUT USING INTERRUPTED PROLENE 8-0 SUTURES (ETHICON) UNDER A MAGNIFYING LOUPE USING POSTERIOR-WALLFIRST TECHNIQUE. DUCT-TO-DUCT BILIARY ANASTOMOSIS IS PERFORMED USING PDS 6-0 (ETHICON) IN AN INTERRUPTED FASHION, OVER AN INDWELLING STENT. IN GROUP A, REPORTED COMPLICATIONS INCLUDED BILIARY LEAKAGE (N-4) WHICH REQUIRED CONSERVATIVE MANAGEMENT, BILIARY STRICTURE (N-3), ASCITES (N-13), ABDOMINAL COLLECTION (N-56) WHICH REQUIRED ULTRASOUND-GUIDED TUBAL DRAINAGE IN TWO PATIENTS AND REEXPLORATION FOR DRAINAGE OF THE COLLECTION, WOUND INFECTION (N-7), AND LATERAL HEPATIC NECROSIS (N-?). IN GROUP B, REPORTED COMPLICATIONS INCLUDED BILIARY LEAKAGE (N-4) WHICH WERE MANAGED CONSERVATIVELY, WOUND INFECTION (N-9), ASCITES (N-8), ABDOMINAL COLLECTION (N-74) WHICH REQUIRED ULTRASOUND-GUIDED TUBAL DRAINAGE IN ONE PATIENT, LATERAL HEPATIC NECROSIS (N-?), AND COLLECTION (N-1) WHICH REQUIRED REEXPLORATION FOR DRAINAGE. SPRAY DIATHERMY IS SIMPLE, RAPID, SAFE, AND INEXPENSIVE, WITH LESS BLOOD LOSS. SPRAY DIATHERMY IS AN EFFECTIVE METHOD OF PARENCHYMAL TRANSECTION WITH SIGNIFICANT LESS BLOOD LOSS AND LESS COST THAN HS, WITH NO INCREASE IN MORBIDITY. THE OVERALL INCIDENCES OF POSTOPERATIVE MORBIDITIES WERE SIGNIFICANTLY LESS IN THE HS GROUP IN THE DONOR AND WERE THE SAME IN RECIPIENTS IN BOTH GROUPS. HS WAS ASSOCIATED WITH EARLIER RECOVERY OF LIVER FUNCTIONS. SPRAY DIATHERMY IS THEREFORE REGARDED AS A SIMPLE, RAPID, AND CHEAP METHOD FOR HEPATIC PARENCHYMAL RESECTION OF THE DONOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1199664 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention