BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 8688852 · Received June 11, 2019

    Report

    Report Number
    2210968-2019-82629
    Event Type
    Injury
    Date Received
    June 11, 2019
    Report Date
    May 14, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN 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. WAS THE CASE DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? IF YES, PLEASE PROVIDE PATIENT DEMOGRAPHICS FOR THE PATIENT THAT EXPERIENCED THE POST-OPERATIVE BLEED THAT REQUIRED BLOOD TRANSFUSION. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? CITATION: OBES SURG (2017) 27: 926¿932; DOI 10.1007/S11695-016-2386-7. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: INTRAOPERATIVE PATTERNS OF GASTRIC MICROPERFUSION DURING LAPAROSCOPIC SLEEVE GASTRECTOMY". AUTHORS: TARIK DELKO, HENRY HOFFMANN, MARKO KRALJEVIC, RAOUL A. DROESER, LINCOLN ROTHWELL, DANIEL OERTLI AND URS ZINGG. CITATION: OBES SURG (2017) 27:926¿932; DOI 10.1007/S11695-016-2386-7. THIS STUDY AIMED TO ASSESS THE REAL-TIME INTRAOPERATIVE GASTRIC MICROPERFUSION PATTERNS OF THE STOMACH DURING LSG USING VISIBLE LIGHT SPECTROSCOPY (VLS). IN 2014, 20 PATIENTS (WITH MEAN AGE 42.9 YEARS MALE N=3, FEMALE N=17) UNDERGOING LSG AT THE DEPARTMENT OF SURGERY, UNIVERSITY HOSPITAL BASEL, SWITZERLAND, PARTICIPATED IN THE STUDY. AFTER COMPLETE MOBILIZATION OF THE GREATER CURVATURE STARTING 3 CM FROM THE PYLORUS, THE TUBE WAS INTRODUCED AND LSG WAS PERFORMED USING AN ECHELON FLEX POWERED ENDOPATH (ETHICON INC, SOMERVILLE, USA) STAPLER WITH 60-MM GREEN RELOADS FOR THE ANTRUM AND BODY AND 60-MM BLUE RELOADS FOR THE FUNDUS TAKING THE VARIABLE WALL THICKNESS OF THE DIFFERENT ANATOMICAL AREAS OF THE STOMACH INTO CONSIDERATION. HEMOSTATIC CONTROL WAS ACHIEVED BY USING MONOPOLAR DIATHERMY OR 3-0 PDS (ETHICON INC, SOMERVILLE, USA) SUTURES. COMPLICATION INCLUDED POSTOPERATIVE BLEED (N=1) THAT REQUIRED A BLOOD TRANSFUSION AND MONITORING IN THE INTENSIVE CARE UNIT. IN CONCLUSION, ASSESSMENT OF MICROPERFUSION PATTERNS OF THE STOMACH DURING LSG USING VLS IS SAFE AND EFFICACIOUS TO USE ALLOWING AN ACCURATE MEASUREMENT OF STO2%. THE UPPER THIRD OF THE STOMACH IS THE ZONE OF REDUCED MICROPERFUSION WITH A SIGNIFICANT DROP OF TISSUE OXYGENATION AFTER SLEEVE RESECTION OF THE STOMACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479321 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention