BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 19378839 · Received May 22, 2024

    Report

    Report Number
    9680654-2024-00053
    Event Type
    Injury
    Date Received
    May 22, 2024
    Report Date
    July 10, 2024
    Manufacturer
    WILLIAM A. COOK AUSTRALIA, PTY LTD
    Product Code
    GAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PART OF THE DEVICE WAS RETURNED FOR EVALUATION. NO IMAGES WERE RECEIVED TO ASSIST THE INVESTIGA REVIEW OF THE DEVICE HISTORY RECORD (DHR) COULD NTION. ADDITIONAL INFORMATION WAS REQUESTED, BUT DESPITE SEVERAL REQUESTS, NO RESPONSE WAS RECEIVED.OT BE CONDUCTED AS THE LOT NUMBER WAS NOT SUPPLIED; THEREFORE, THE MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED. REVIEW OF THE INSTRUCTIONS FOR USE (IFU) SUPPLIED WITH THE DEVICE FOUND IT CONTAINED APPROPRIATE WARNINGS, PRECAUTIONS, AND INSTRUCTIONS TO THE USER, INCLUDING: STEPS FOR INSERTION NOTE: THE INSERTION POINT FOR THE NATHANSON LIVER RETRACTOR DEPENDS UPON THE PROCEDURE BEING PERFORMED, SIZE OF THE PATIENT AND PERSONAL PREFERENCE OF THE SURGEON. FOR EXAMPLE, WHEN PERFORMING A NISSEN FUNDOPLICATION, AN OPTIMAL SITE MAY BE THE POINT INFERIOR TO THE XIPHOID PROCESS. STEP 1 COMMENCE INSUFFLATION OF THE PERITONEAL CAVITY IN THE NORMAL MANNER. STEP 2 UPON OBTAINING SET MAXIMUM PRESSURE INSERT A 5 MM TROCAR. REMOVE THE TROCAR AND ENLARGE THE TRACT, IF NECESSARY, WITH A PAIR OF ARTERY FORCEPS. STEP 3 HOLDING THE NATHANSON LIVER RETRACTOR BY THE HANDLE AND MAINTAINING THE CURVED RADIUS IN A VERTICAL POSITION, INSERT THE RETRACTOR WITH A TWISTING MOTION. DO NOT CONNECT THE NATHANSON LIVER RETRACTOR TO THE RETRACTOR ARM. STEP 4 UNDER DIRECT VISION, MANEUVER THE CURVED EDGE OF THE NATHANSON LIVER RETRACTOR IN A SUPERIOR DIRECTION UNDER THE LEFT LOBE OF THE LIVER. STEP 5 CONTINUE PLACEMENT OF THE PORTS. WHEN THIS IS COMPLETE, ATTACH THE NATHANSON LIVER RETRACTOR TO THE RETRACTOR ARM AND ELEVATE THE LIVER TO THE DESIRED POSITION. THERE IS NO EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IF ADDITIONAL INFORMATION IS RECEIVED AFTER THE COMPLAINT INVESTIGATION HAS BEEN COMPLETED, THE NEW INFORMATION SHALL BE REVIEWED TO DETERMINE IF THE INFORMATION RECEIVED IMPACTS THE INVESTIGATION. FROM THE INFORMATION RECEIVED A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE MANDATORY REQUIREMENT TO ALWAYS CHECK COMPLAINTS HISTORY DURING A COMPLAINT INVESTIGATION WILL ENSURE TRENDS ARE CONSTANTLY MONITORED. AFTER CONSIDERING THIS EVENT THE BENEFITS OF USING THIS DEVICE STILL OUTWEIGH THE KNOWN RISKS.

    Additional Manufacturer Narrative · 0

    EVENT INFORMATION WAS TAKEN FROM A JOURNAL ARTICLE: ¿LIVER ABSCESS AND PROLONGED POSTOPERATIVE INTRA-ABDOMINAL FREE AIR WITHOUT ANASTOMOTIC LEAKAGE AFTER LAPAROSCOPIC GASTRECTOMY.¿ DOI: 10.1159/000524728.

    Description of Event or Problem · 0

    EVENT INFORMATION TAKEN FROM JOURNAL ARTICLE: ¿LIVER ABSCESS AND PROLONGED POSTOPERATIVE INTRA-ABDOMINAL FREE AIR WITHOUT ANASTOMOTIC LEAKAGE AFTER LAPAROSCOPIC GASTRECTOMY.¿ LIVER ABSCESS, PROBABLY DUE TO THE USE OF NATHANSON LIVER RETRACTOR (NLR) AND PROLONGED POSTOPERATIVE INTRA-ABDOMINAL FREE AIR WITHOUT ANASTOMOTIC LEAKAGE AFTER LAPAROSCOPIC GASTRECTOMY: AN 84-YEAR-OLD THIN, I.E., BODY MASS INDEX OF 17.8, WOMAN WITH GASTRIC CANCER UNDERWENT LAPAROSCOPIC DISTAL GASTRECTOMY AND LYMPH NODE DISSECTION FOLLOWED BY ROUX-EN-Y RECONSTRUCTION. DURING THE OPERATION, NATHANSON LIVER RETRACTOR (NLR) WAS USED TO PRESS THE LEFT LOBE OF THE LIVER. THE PATIENT RECOVERED UNEVENTFULLY AND WAS DISCHARGED ON THE 9TH POSTOPERATIVE DAY. THE PATIENT, HOWEVER, DEVELOPED ABDOMINAL PAIN ON THE DAY OF DISCHARGE. 2 DAYS AFTER DISCHARGE, THE PATIENT WAS TAKEN TO HOSPITAL BY AMBULANCE DUE TO THE MARKED AGGRAVATION OF THE SYMPTOMS. LABORATORY TESTS SHOWED INFLAMMATORY FINDINGS AND LIVER DYSFUNCTION, WHITE BLOOD CELL COUNT OF 27,400/¿L, C-REACTIVE PROTEIN OF 28.8 MG/DL, ASPARTATE AMINOTRANSFERASE OF 143 U/L, AND ALANINE AMINOTRANSFERASE OF 51 U/L. ULTRASOUND SHOWED AN OVAL MASS 4 CM IN SIZE IN THE LIVER SEGMENT 3. CT SHOWED A LOW INTENSITY LESION IN THE LIVER, NO ABDOMINAL DISTENTION, AND MASSIVE FREE AIR IN THE ABDOMEN. THEY HIGHLY SUSPECTED ANASTOMOTIC LEAKAGE WITH ABDOMINAL ABSCESS AND DID EMERGENT DIAGNOSTIC LAPAROSCOPY. ON LAPAROSCOPY, SLIGHT LIVER SWELLING AT THE PRESSURE SITE OF THE NLR AND SUPERFICIAL BAND-SHAPED COLOUR CHANGE ON THE LEFT LOBE OF THE LIVER WERE OBSERVED. HOWEVER, NEITHER ANASTOMOTIC LEAKAGE NOR POLLUTED ASCITES WAS OBSERVED. THEY THEREFORE, JUDGED THAT MASSIVE FREE AIR IN THE ABDOMEN SHOULD BE CAUSED BY PROLONGED FREE AIR RETENTION AFTER LAPAROSCOPIC DISTAL GASTRECTOMY. BASED ON THE IDEA THAT PRESUMED LIVER ABSCESS COULD BE MANAGEABLE WITH TRANSCUTANEOUS APPROACH, THEY ONLY INSERTED DRAINS AROUND THE ANASTOMOTIC SITES AND INFRA-DIAPHRAGMATIC SPACE TO FINISH THE OPERATION. TWO DAYS AFTER THE EMERGENT OPERATION, ULTRASOUND-GUIDED PERCUTANEOUS ASPIRATION, WITHOUT SUCCESSFUL CATHETER INSERTION, INTO THE PRESUMED ABSCESS IN THE LIVER SEGMENT 3 WAS DONE TO THE PATIENT DUE TO THE PROLONGED UNPLEASANT SYMPTOMS AND PERSISTENT INFLAMMATORY FINDINGS. THE BACTERIUM ESCHERICHIA COLI WAS DETECTED IN THE BLOOD AND ABSCESS CULTURES. ANTIBIOTIC THERAPY USING MEROPENEM BROUGHT ABOUT GRADUAL IMPROVEMENT OF BOTH THE INFLAMMATORY FINDINGS AND SYMPTOMS, AND THE PATIENT WAS DISCHARGED ON THE 15TH DAY AFTER ABSCESS ASPIRATION. .

    Description of Event or Problem · 0

    EVENT INFORMATION TAKEN FROM JOURNAL ARTICLE: ¿LIVER ABSCESS AND PROLONGED POSTOPERATIVE INTRA-ABDOMINAL FREE AIR WITHOUT ANASTOMOTIC LEAKAGE AFTER LAPAROSCOPIC GASTRECTOMY.¿ LIVER ABSCESS, PROBABLY DUE TO THE USE OF NATHANSON LIVER RETRACTOR (NLR) AND PROLONGED POSTOPERATIVE INTRA-ABDOMINAL FREE AIR WITHOUT ANASTOMOTIC LEAKAGE AFTER LAPAROSCOPIC GASTRECTOMY: AN 84-YEAR-OLD THIN, I.E., BODY MASS INDEX OF 17.8, WOMAN WITH GASTRIC CANCER UNDERWENT LAPAROSCOPIC DISTAL GASTRECTOMY AND LYMPH NODE DISSECTION FOLLOWED BY ROUX-EN-Y RECONSTRUCTION. DURING THE OPERATION, NATHANSON LIVER RETRACTOR (NLR) WAS USED TO PRESS THE LEFT LOBE OF THE LIVER. THE PATIENT RECOVERED UNEVENTFULLY AND WAS DISCHARGED ON THE 9TH POSTOPERATIVE DAY. THE PATIENT, HOWEVER, DEVELOPED ABDOMINAL PAIN ON THE DAY OF DISCHARGE. 2 DAYS AFTER DISCHARGE, THE PATIENT WAS TAKEN TO HOSPITAL BY AMBULANCE DUE TO THE MARKED AGGRAVATION OF THE SYMPTOMS. LABORATORY TESTS SHOWED INFLAMMATORY FINDINGS AND LIVER DYSFUNCTION, WHITE BLOOD CELL COUNT OF 27,400/L, C-REACTIVE PROTEIN OF 28.8 MG/DL, ASPARTATE AMINOTRANSFERASE OF 143 U/L, AND ALANINE AMINOTRANSFERASE OF 51 U/L. ULTRASOUND SHOWED AN OVAL MASS 4 CM IN SIZE IN THE LIVER SEGMENT 3. CT SHOWED A LOW INTENSITY LESION IN THE LIVER, NO ABDOMINAL DISTENTION, AND MASSIVE FREE AIR IN THE ABDOMEN. THEY HIGHLY SUSPECTED ANASTOMOTIC LEAKAGE WITH ABDOMINAL ABSCESS AND DID EMERGENT DIAGNOSTIC LAPAROSCOPY. ON LAPAROSCOPY, SLIGHT LIVER SWELLING AT THE PRESSURE SITE OF THE NLR AND SUPERFICIAL BAND-SHAPED COLOUR CHANGE ON THE LEFT LOBE OF THE LIVER WERE OBSERVED. HOWEVER, NEITHER ANASTOMOTIC LEAKAGE NOR POLLUTED ASCITES WAS OBSERVED. THEY THEREFORE, JUDGED THAT MASSIVE FREE AIR IN THE ABDOMEN SHOULD BE CAUSED BY PROLONGED FREE AIR RETENTION AFTER LAPAROSCOPIC DISTAL GASTRECTOMY. BASED ON THE IDEA THAT PRESUMED LIVER ABSCESS COULD BE MANAGEABLE WITH TRANSCUTANEOUS APPROACH, THEY ONLY INSERTED DRAINS AROUND THE ANASTOMOTIC SITES AND INFRA-DIAPHRAGMATIC SPACE TO FINISH THE OPERATION. TWO DAYS AFTER THE EMERGENT OPERATION, ULTRASOUND-GUIDED PERCUTANEOUS ASPIRATION, WITHOUT SUCCESSFUL CATHETER INSERTION, INTO THE PRESUMED ABSCESS IN THE LIVER SEGMENT 3 WAS DONE TO THE PATIENT DUE TO THE PROLONGED UNPLEASANT SYMPTOMS AND PERSISTENT INFLAMMATORY FINDINGS. THE BACTERIUM ESCHERICHIA COLI WAS DETECTED IN THE BLOOD AND ABSCESS CULTURES. ANTIBIOTIC THERAPY USING MEROPENEM BROUGHT ABOUT GRADUAL IMPROVEMENT OF BOTH THE INFLAMMATORY FINDINGS AND SYMPTOMS, AND THE PATIENT WAS DISCHARGED ON THE 15TH DAY AFTER ABSCESS ASPIRATION. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1788204 UNKNOWN GAD RETRACTOR - MURDOCH MECHANICAL ARM GAD WILLIAM A. COOK AUSTRALIA, PTY LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Hospitalization