BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH XCEL TROCAR

    MDR report key: 11718642 · Received April 23, 2021

    Report

    Report Number
    3005075853-2021-02238
    Event Type
    Injury
    Date Received
    April 23, 2021
    Date of Event
    December 3, 2018
    Report Date
    March 25, 2021
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) DATE SENT: 4/23/2021 H11=CORRECTED DATA=B2; E4; H6 B2. IS REQUIRED INTERVENTION: YES E4. REPORTER ALSO SENT REPORT TO FDA? NO H6: 6. HEALTH EFFECT - CLINICAL CODE:ADD OR UPDATE CLINICAL CODES TO: HEMORRHAGE/BLEEDING (E0506); HERNIA (E2319); INSUFFICIENT INFORMATION (E2401); AND SEROMA (E0307) H6: HEALTH EFFECT-IMPACT CODE: ADD OR UPDATE TO MODIFIED SURGICAL PROCEDURE (F1906); AND INSUFFICIENT INFORMATION (F24).

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH #: UNKNOWN. PUBLICATION DATE OF JOURNAL ARTICLE IS DECEMBER 3, 2018. 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. AS THE LOT/BATCH WAS NOT PROVIDED; A MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REVIEW OF THE FOLLOWING JOURNAL ARTICLE, TITLE: FEASIBILITY OF TOTALLY EXTRAPERITONEAL (TEP) LAPAROSCOPIC HERNIA REPAIR IN ELDERLY PATIENTS AUTHORS: Y. CHUNG , J. W. CHOI2, H. C. KIM, S. H. KIM, S. I. CHOI. CITATION:HERNIA (2019) 23:299¿303 HTTPS://DOI.ORG/10.1007/S10029-018-1869-Y. A RETROSPECTIVE STUDY THAT REVIEWED CLINICAL RECORDS OF INGUINAL HERNIA PATIENTS WHO HAD UNDERGONE HERNIA REPAIRS BY EXPERIENCED SURGEONS FROM AUGUST 2007 TO SEPTEMBER 2016. A TOTAL OF 425 CASES WERE DOCUMENTED. THE PATIENTS WERE DIVIDED INTO TWO GROUPS ACCORDING TO AGE: ONE GROUP INCLUDED 317 (74.6%) PATIENTS PATIENTS WHO WERE YOUNGER THAN 70 YEARS AND THE OTHER GROUP INCLUDED 108 (25.4%) PATIENTS THOSE AGED 70 YEARS AND OLDER. THE AVERAGE FOLLOW-UP PERIOD WAS 7 DAYS AFTER THE SURGERY. A 10-MM BLUNT-TIP TROCAR (ETHICON)WAS INSERTED INTO THE PREPERITONEAL SPACE WITH INSUFFLATION OF CARBON DIOXIDE TO A PRESSURE OF 10¿12 MMHG. UNDER DIRECT ENDOSCOPIC VISION, A 5-MM TROCAR (ETHICON) PORT WAS PLACED DIRECTLY ABOVE THE SYMPHYSIS PUBIS. THE EXTRAPERITONEAL SPACE WAS DISSECTED AND CREATED BY ENDODISSECTORS WITH DIATHERMY. DISSECTION OF THE HERNIA SAC WAS PERFORMED TO EXPOSE THE SPERMATIC CORD/ROUND LIGAMENT AND ALL HERNIA ORIFICES. AFTER DISSECTION OF THE INGUINAL REGION AND REDUCTION OF THE HERNIA SAC WAS COMPLETED, A MESH PROSTHESIS 12 × 9 OR 13 × 10 CM, PROLENE MESH (ETHICON) WAS INSERTED TO COVER ALL POTENTIAL HERNIA ORIFICES. THE MESH FIXATION WAS DONE WITH ENDOSCOPIC TACKS. THE PATIENTS WERE TRANSFERRED TO THE POSTANESTHESIA RECOVERY ROOM FOR OBSERVATION BEFORE RETURNING TO THE HOSPITAL WARD. THE PATIENTS WERE USUALLY DISCHARGED THE NEXT DAY. REPORTED POSTOPERATIVE COMPLICATIONS IN YOUNGER THAN 70 YEARS PATIENTS BLEEDING (N=2) ,DYSURIA (N=20), SEROMA (N=6) AND RECURRENCE (N=1).POSTOPERATIVE COMPLICATIONS IN AGED 70 YEARS AND OLDER BLEEDING (N=1) ,DYSURIA (N=11), SEROMA (N=1), RECURRENCE(N=2). THE LENGTH OF HOSPITAL STAY IN ELDERLY GROUP WAS LONGER THAN THAT IN THE YOUNGER GROUP. IN CONCLUSION LAPAROSCOPIC TEP HERNIA REPAIR CAN BE PERFORMED SAFELY IN ELDERLY PATIENTS WITHOUT DIFFERENCES IN PERIOPERATIVE COMPLICATIONS AND RECURRENCE RATE COMPARED TO THAT IN A YOUNGER POPULATION DESPITE A LONGER HOSPITAL STAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612635 ENDOPATH XCEL TROCAR LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R