BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILS 29MM, CURVED

    MDR report key: 14436630 · Received May 19, 2022

    Report

    Report Number
    3005075853-2022-03265
    Event Type
    Injury
    Date Received
    May 19, 2022
    Date of Event
    February 2, 2021
    Report Date
    May 18, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036003465
    PMA / PMN Number
    K983536
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). BATCH # UNKNOWN. 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/BATCH NUMBER HAS NOT BEEN PROVIDED. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. HOWEVER, IF THE PRODUCT OR PRODUCT ID NUMBERS ARE RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICES MENTIONED IN THIS ARTICLE CAUSED/CONTRIBUTED TO THE REPORTED EVENTS IN THE ARTICLE? IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FIELD AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE; TITLE: NATURAL ORIFICE VERSUS CONVENTIONAL MINI-LAPAROTOMY FOR SPECIMEN EXTRACTION AFTER REDUCED-PORT LAPAROSCOPIC SURGERY FOR COLORECTAL CANCER: PROPENSITY SCORE-MATCHED COMPARATIVE STUDY AUTHORS: SHENG-CHI CHANG1,2 · TSUNG-HAN LEE2 · YI-CHANG CHEN1 · MEI-TSZ CHEN3 · HUNG-CHANG CHEN1 · TAO-WEI KE1 · YUAN-YAO TSAI1 · ABE FINGERHUT4,5 · WILLIAM TZU-LIANG CHEN1 CITATION: SURGICAL ENDOSCOPY (2022) 36:155¿166. HTTPS://DOI.ORG/10.1007/S00464-020-08250-8. THIS RETROSPECTIVE CASE MATCHED STUDY OF A PROSPECTIVELY COLLECTED DATA WAS TO INVESTIGATE THE IMPACT OF NATURAL ORIFICE SPECIMEN EXTRACTION (NOSE) COMPARED TO CONVENTIONAL SPECIMEN EXTRACTION IN PATIENTS WHO UNDERWENT REDUCED PORT LAPAROSCOPIC SURGERY (RPLS) FOR COLORECTAL CANCER. A TOTAL OF 119 PATIENTS WHO UNDERWENT ELECTIVE SIGMOID OR UPPER RECTAL CANCER RESECTION VIA RPLS BETWEEN APRIL 2013 AND JULY 2019 WERE INCLUDED. THE PATIENTS WERE DIVIDED INTO TWO GROUPS: RPLS WITH NOSE (RPLS-NOSE) IN 58 PATIENTS [33 WERE MALES; MEAN AGE OF 63.2 ± 11.9 YEARS; MEAN BMI OF 21 (36.2)] AND RPLS WITH CONVENTIONAL SPECIMEN EXTRACTION BY MINI-LAPAROTOMY (RPLS-CSE) IN 61 PATIENTS [25 WERE MALES; MEAN AGE OF 65.1 ± 12.2 YEARS; MEAN BMI OF 16 (26.2)]. AFTER A STANDARD LAPAROSCOPIC RESECTION TECHNIQUE, AND ISOLATION OF THE SPECIMEN, THE DISTAL RECTAL LUMEN WAS CLOSED WITH A NONABSORBABLE SUTURE (ETHIBOND EXCEL¿ POLYESTER SUTURE, ETHICON, USA). IN THE RPLS-NOSE GROUP, AN ARTICULATING LINEAR STAPLER (EC60A, BLUE CARTILAGE) WAS USED. IN THE RPLS-CSE GROUP, AN ARTICULATING LINEAR STAPLER (ECHELON FLEX 60 ENDOPATH STAPLER [EC60A] GREEN CARTILAGE; ETHICON, USA) AND A CIRCULAR STAPLER (CDH29A OR CDH33A; ETHICON, USA) WERE USED. REPORTED COMPLICATIONS INCLUDE ANASTOMOTIC SITE BLEEDING (N=1), IATROGENIC BLADDER INJURY (N=1), ANASTOMOTIC LEAKAGE (N=1), INTRAABDOMINAL ABSCESS (N=1), INTRAABDOMINAL INFECTION (N=2), PROLONG ILEUS (N=2) REQUIRING READMISSION IN ONE PATIENT, AND WOUND INFECTION (N=2) REQUIRING READMISSION IN ONE PATIENT. IN CONCLUSION, NOSE ENHANCES THE ADVANTAGES OF RPLS BY AVOIDING THE NEED FOR ABDOMINAL WALL SPECIMEN EXTRACTION IN PATIENTS WITH TUMOR DIAMETER = 5 CM. SURGICAL AND ONCOLOGIC SAFETY ARE COMPARABLE TO RPLS WITH CSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1975969 ILS 29MM, CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. CDH29A 10705036003465

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention