BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 15614608 · Received October 17, 2022

    Report

    Report Number
    2210968-2022-08468
    Event Type
    Injury
    Date Received
    October 17, 2022
    Date of Event
    May 30, 2022
    Report Date
    October 17, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 10/17/2022. 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. 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. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS REPORTED VIA 2210968-2022-08467 AND 2210968-2022-08468. CITATION: LANGENBECK'S ARCHIVES OF SURGERY (2022) 407:2151¿2159.

    Description of Event or Problem · 0

    TITLE: SINGLE-LAYER CONTINUOUS DUCT-TO-MUCOSA PANCREATICOJEJUNOSTOMY: ¿HOW WE DO IT¿ THE AIM OF THE CURRENT STUDY WAS TO EVALUATE THE FEASIBILITY OF OUR SIMPLIFIED TECHNIQUE, SINGLE-LAYER CONTINUOUS DUCT-TO MUCOSA PANCREATICOJEJUNOSTOMY. FROM JANUARY TO FEBRUARY 2020, 20 PATIENTS WHO UNDERWENT WHIPPLE¿S PROCEDURE WITH THE NEW TECHNIQUE PERFORMED BY A SINGLE SURGEON WERE INCLUDED IN THE STUDY. THERE WERE 13 MALE AND 7 FEMALE PATIENTS WITH A MEAN AGE OF 66 YEARS (RANGE 47-79 YEARS) AND A MEAN BMI OF 24.2 KG/M2 (RANGE 20.7-29.1). DURING THE WHIPPLE¿S PROCEDURE, HEPATOJEJUNOSTOMY WAS PERFORMED USING 4¿0/5¿0 PDS-II SUTURE (ETHICON). ANTE-COLIC GASTROJEJUNAL ANASTOMOSIS WAS ACCOMPLISHED BY A CIRCULAR STAPLER (UNKNOWN MANUFACTURER). HEMOSTASIS AT THE PANCREATIC STUMP WAS SECURED WITH TRANSFIXION WITH 5¿0 PROLENE (ETHICON) BEFORE THE START OF PANCREATICOJEJUNOSTOMY. A SINGLE 4¿0 PROLENE 26 MM, 1/2C DOUBLE ENDS SUTURE (ETHICON) WAS USED FOR THE ENTIRE CONTINUOUS DUCT-TO-MUCOSA PANCREATICOJEJUNOSTOMY ANASTOMOSIS. THE REPORTED COMPLICATIONS INCLUDED POSTOPERATIVE PANCREATIC FISTULA (N=2), BIOCHEMICAL PANCREATIC LEAK (N=3), INTRAABDOMINAL INFECTION (N=2), DELAYED GASTRIC EMPTYING (N=4), POST-PANCREATECTOMY HEMORRHAGE (N=1), CHYLE LEAK (N=3). IN CONCLUSION, SINGLE-LAYER CONTINUOUS DUCT-TO-MUCOSA PANCREATICOJEJUNOSTOMY IS A SIMPLIFIED AND FEASIBLE METHOD FOR PANCREATIC ANASTOMOSIS. FURTHER STUDIES ARE WARRANTED TO EVALUATE THE INDICATIONS OR CONTRAINDICATIONS AND EFFICACY OF PREVENTING PANCREATIC FISTULA WITH OUR NEW TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2933857 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention