BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 19048068 · Received April 4, 2024

    Report

    Report Number
    2210968-2024-03919
    Event Type
    Injury
    Date Received
    April 4, 2024
    Date of Event
    May 29, 2023
    Report Date
    April 4, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: BMC SURGERY (2023) 23:146; HTTPS://DOI.ORG/10.1186/S12893-023-02054-Y.

    Description of Event or Problem · 0

    TITLE: CHEN¿S PENETRATING-SUTURE TECHNIQUE FOR PANCREATICOJEJUNOSTOMY FOLLOWING PANCREATICODUODENECTOMY. THIS STUDY PRESENTS A NEW APPROACH CALLED CHEN¿S PENETRATING-SUTURE TECHNIQUE FOR PANCREATICOJEJUNOSTOMY (PPJ), WHICH INVOLVES END-TO-SIDE PANCREATICOJEJUNOSTOMY BY SUTURE PENETRATING THE FULL-THICKNESS OF THE PANCREAS AND JEJUNUM, AND EVALUATES ITS SAFETY AND EFFICACY. BETWEEN MAY 2006 AND JULY 2018, 193 PATIENTS WITH PERIAMPULLARY MALIGNANCIES WHO UNDERWENT THE NEW CHEN¿S PENETRATING-SUTURE TECHNIQUE AFTER A PANCREATICODUODENECTOMY WERE INCLUDED IN THE STUDY. THERE WERE 118 MALES AND 75 FEMALES WITH A MEAN AGE OF 67.6 YEARS (RANGE, 25 TO 85 YEARS). FOR ALL PATIENTS, AFTER THE PANCREAS WAS TRANSECTED, THE ANASTOMOSIS BETWEEN THE PANCREATIC REMNANT AND THE JEJUNAL SIDE WALL BEGINS. THE FIRST 4¿0 VICRYL (ETHICON) SUTURE COMPLETELY PENETRATES THE PANCREATIC PARENCHYMA FROM THE ANTERIOR TO POSTERIOR, AND THEN CONTINUOUSLY PENETRATES THE POSTERIOR WALL TO THE ANTERIOR WALL OF THE JEJUNUM LOOP. SUBSEQUENTLY, THE FIRST SUTURE IS COMPLETED AND WITHDRAWN AFTER PENETRATING THE ENTIRE PANCREATIC PARENCHYMA AND THE FULL-THICKNESS JEJUNUM WALL. THEN, THE SAME METHOD WAS USED TO PERFORM THE SECOND, THIRD SUTURE AND UNTIL THE COMPLETION OF ALL OF 6¿8 SUTURES. AFTER PUTTING THE PANCREATIC CATHETER TO THE JEJUNUM, THE KNOT WAS TIGHTENED SLOWLY. ADDITIONAL SUTURES WERE PERFORMED BETWEEN THE SEROMUSCULAR LAYERS OF THE ANTERIOR AND POSTERIOR WALLS OF JEJUNUM LOOP AND THE PANCREATIC RENMANT TO STRENGTHEN AND ACHIEVE THE PANCREAS-JEJUNUM ANASTOMOSIS. FURTHER RECONSTRUCTION OF THE CONTINUITY OF THE DIGESTIVE TRACT INCLUDES END-TO-SIDE CHOLANGIOJEJUNOSTOMY AND END-TO-SIDE GASTROJEJUNOSTOMY. AFTER SURGICAL RECONSTRUCTION DURING PANCREATICODUODENECTOMY, TWO DRAINS WERE PLACED IN THE VICINITY OF THE PANCREATICOJEJUNOSTOMY AND THE CHOLANGIOJEJUNOSTOMY WITHOUT SUCTION. THE DRAINAGE TUBE REMAINED INTACT 7¿9 DAYS AFTER OPERATION. REPORTED COMPLICATIONS INCLUDED DELAYED GASTRIC EMPTYING (N=10) AND POSTOPERATIVE PANCREATIC FISTULA (N=11). IN CONCLUSION, PANCREATICOJEJUNOSTOMY IS A SIMPLE, SAFE, AND RELIABLE TECHNIQUE WITH IDEAL POSTOPERATIVE CLINICAL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2267441 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention