BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH*PROBE PLUS II SHAFT

    MDR report key: 10580151 · Received September 24, 2020

    Report

    Report Number
    3005075853-2020-04877
    Event Type
    Injury
    Date Received
    September 24, 2020
    Report Date
    August 31, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K912492
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PUBLICATION YEAR OF 2018. BATCH # UNK THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. 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 DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    TITLE : EVOLUTION OF THE KONYANG STANDARD METHOD FOR SINGLE INCISION LAPAROSCOPIC CHOLECYSTECTOMY: THE RESULT FROM A THOUSAND CASE OF A SINGLE CENTER EXPERIENCE AUTHORS : MIN KYU KIM, IN SEOK CHOI, JU IK MOON, SANG EOK LEE, DAE SUNG YOON, SEONG UK KWON, WON JUN CHOI, NAK SONG SUNG, SI MIN PARK. CITATION: ANNALS OF SURGICAL TREATMENT AND RESEARCH 2018;95(2):80-86; DOI: 10.4174/ASTR.2018.95.2.80. THIS REPORT AIMED TO EVALUATE THE ADEQUACY AND FEASIBILITY OF THE KONYANG STANDARD METHOD (KSM) FOR SINGLE INCISION LAPAROSCOPIC CHOLECYSTECTOMY (SILC). A TOTAL OF 1005 PATIENTS (N=459 MALES, N=546 FEMALES, MEAN AGE: 52 YEARS, AGE RANGE: 16-88 YEARS) WERE INCLUDED IN THE STUDY. BETWEEN APRIL 2010 AND SEPTEMBER 2012, 323 PATIENTS UNDERWENT SILC WITH THE KSM USING A HAND-MADE 3-CHANNEL (3-TROCAR) SINGLE PORT. FROM OCTOBER 2012 TO AUGUST 2016, 645 PATIENTS UNDERWENT SILC WITH KSM USING A MODIFIED 4-CHANNEL TECHNIQUE WITH A SNAKE RETRACTOR FOR EXPOSURE OF THE HEPATOCYSTIC TRIANGLE (CALOT TRIANGLE) (MODIFIED KSM (MKSM)). SINCE SEPTEMBER 2016, THE COMMERCIAL 4-CHANNEL (GLOVE) PORT HAS BEEN USED FOR SIMPLICITY IN 37 PATIENTS (COMMERCIALLY MODIFIED KSM (C-MKSM)). THE FLEXIBLE VIDEOSCOPE, LONG ARTICULATED ENDO-ROTICULATOR LAPAROSCOPIC INSTRUMENT, A SUCTION-HOOK BOVIE (ENDOPATH PROBE PLUS II PISTOL GRIP HANDLE, ETHICON) AND 5- AND 10-MM HEM-O-LOK CLIPS ARE USED IN THE KSM. THE DISSECTOR AND SUCTION-HOOK BOVIE WERE USED IN THE LEFT HAND TO DISSECT THE HEPATOCYSTIC TRIANGLE BOUNDARY. IF THE GALLBLADDER NECK IS DISSECTED FREE OF THE LIVER SURFACE, A ¿WINDOW¿ IS CREATED IN THE HEPATOCYSTIC TRIANGLE CROSSED BY THE CYSTIC DUCT AND ARTERY (DISSECTION OF THE HEPATOCYSTIC TRIANGLE). COMPLAINT INCLUDED GALLBLADDER BED BLEEDING (N=16) WHICH WAS CONTROLLED BY LAPAROSCOPIC SUTURE LIGATION, BILE DUCT INJURY (N=2) TREATED WITH LAPAROSCOPIC PRIMARY SUTURE REPAIR WITH T-TUBE INSERTION, DUODENAL INJURY/PERFORATION (N=1) AND WAS TREATED WITH LAPAROSCOPIC SUTURE REPAIR, BILOMA (N=3). IN CONCLUSION, THE FINDINGS OF THIS STUDY SUGGEST THAT THE MODIFIED KSM USING A 4-CHANNEL SINGLE PORT AND SNAKE RETRACTOR MAY BE THE SAFEST AND LEAST INVASIVE METHOD FOR SILC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1047799 ENDOPATH*PROBE PLUS II SHAFT LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GENERATOR