BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH XCEL TROCAR

    MDR report key: 8845250 · Received July 31, 2019

    Report

    Report Number
    3005075853-2019-20914
    Event Type
    Injury
    Date Received
    July 31, 2019
    Report Date
    July 15, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: UNKNOWN. BATCH # UNKNOWN. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. 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 THE REPORTED ISSUES ARE RELATED TO AN ALLEGED DEFICIENCY OF AN ETHICON DEVICE?

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: LAPAROSCOPIC INGUINAL HERNIA REPAIR BY INTRAPERITONEAL ONLAY MESH (IPOM) TECHNIQUE IN SPECIFIC CASES AS AN ALTERNATIVE METHOD AUTHORS: YOUNG BAE JEON, M.D.; MYUNG JIN KIM, M.D.; KYUNG YUL HUR, M.D., PH.D. CITATION: JOURNAL OF MINIMALLY INVASIVE SURGERY. 2014; 17(2). DOI: HTTP://DX.DOI.ORG/10.7602/JMIS.2014.17.2.30. DESPITE ADVANCEMENTS IN SURGERY, LAPAROSCOPIC TOTALLY EXTRAPERITONEAL (TEP) REPAIR FOR INGUINAL HERNIA IN PATIENTS WITH PREVIOUS LOWER ABDOMINAL SURGERIES HAS BEEN A BURDEN TO SURGEONS. THIS STUDY WAS CONDUCTED IN ORDER TO ASSESS THE FEASIBILITY OF LAPAROSCOPIC INTRAPERITONEAL ONLAY MESH (IPOM) HERNIA REPAIR AS AN ALTERNATIVE METHOD FOR THESE CASES. FROM MAY 2006 TO NOVEMBER 2010, A TOTAL OF 48 IPOM REPAIRS WERE PERFORMED IN 43 PATIENTS (AGE: 61 ± 16 YEARS; 37 MALE AND 6 FEMALE PATIENTS). DURING THE SURGICAL PROCEDURE, THE PATIENT WAS LAID SUPINE IN TRENDELENBURG POSITION. AN ENDOPATH XCEL 11 MM TROCAR (ETHICON) WAS INSERTED INTO THE PERITONEAL CAVITY AT SUPRAUMBILICAL AREA BY OPEN HASSON TECHNIQUE, THROUGH WHICH 45-DEGREE LAPAROSCOPE WAS INTRODUCED. A PROCEED 15 × 12 CM SIZED DUAL FACING SURGICAL MESH (ETHICON) WITH LONG NON-ABSORBABLE STITCH ON THE CORNER OF THE MESH FOR TRANSFASCIAL FIXATION WAS ROLLED AND PASSED THROUGH THE 11 MM TROCAR INTO THE PERITONEAL CAVITY, AND THEN THE MESH WAS MANIPULATED TO LIE FLAT AGAINST THE POSTERIOR INGUINAL FLOOR. REPORTED INTRAOPERATIVE COMPLICATIONS INCLUDED URINARY BLADDER INJURY (N-1) AND REPAIRED IMMEDIATELY WITHOUT NEED FOR CONVERSION, SMALL BOWEL INJURY (N-1) IN WHICH THE AUTHORS EXTENDED INCISION AND REPAIRED THE INJURED SMALL BOWEL IMMEDIATELY, AND TRANSIENT INGUINAL PAIN (N-2) WHICH REQUIRED TREATMENT WITH ANALGESICS. REPORTED POST-OPERATIVE COMPLICATIONS INCLUDED SWELLING OR SEROMA (N-2) IN WHICH THE EVENTS WERE RESOLVED SPONTANEOUSLY WITHOUT ANY INTERVENTION IN 4 TO 6 WEEKS AND RECURRENCE (N-1) WHICH REQUIRED TREATMENT BY ANTERIOR APPROACH USING PROLENE BILAYER MESH (ETHICON). NOWADAYS, LAPAROSCOPIC SURGERY HAS BECOME THE GOLD STANDARD PROCEDURE IN MANY SURGICAL FIELDS. THOUGH LAPAROSCOPIC IPOM REPAIR FOR INGUINAL HERNIA IS NOT A STANDARD METHOD, IT CAN BE PERFORMED FOR SPECIFIC CASES OF RECURRENT HERNIAS WHICH HAVE DIFFICULTIES IN APPROACHING USUAL PLANE OF REPAIR AS AN ALTERNATIVE OPTION WITH PROFICIENT SKILLS AND CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643119 ENDOPATH XCEL TROCAR LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1