BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLICATOR

    MDR report key: 959803 · Received December 4, 2007

    Report

    Report Number
    1226693-2007-00005
    Event Type
    Injury
    Date Received
    December 4, 2007
    Date of Event
    October 7, 2007
    Report Date
    December 3, 2007
    Manufacturer
    NDO SURGICAL, INC.
    Product Code
    KOG
    PMA / PMN Number
    K032820
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AMENDED BASED ON RECEIPT OF ADDITIONAL INFORMATION. BACKGROUND: IN 2007, MALE PATIENT WITH A HISTORY OF NON-ACID REFLUX DUE TO A PREVIOUS VAGOTOMY RECEIVED PLICATOR TREATMENT FROM DR. AT HOSPITAL IN A FOREIGN COUNTRY. THE PATIENT HAD ALSO PREVIOUSLY UNDERGONE A GASTRIC RESECTION WITH ROUX-EN-Y BYPASS. TWO DAYS SUBSEQUENT TO RECEIVING PLICATOR TREATMENT, THE PATIENT DEVELOPED EMPYEMA IN THE LEFT PLEURA. THE PATIENT WAS REPORTEDLY HOSPITALIZED FOR ONE WEEK AND TREATED FOR THE INFECTION WITH A THORACOTOMY. THE PATIENT HAS SUBSEQUENTLY RECOVERED WITHOUT FURTHER INCIDENT AND HAS BEEN DISCHARGED. DR. REPORTS THAT THE PHYSICIAN WHO TREATED THE PATIENT'S EMPYEMA REPORTED THAT THE PLICATOR IMPLANT NEEDLES HAD PENETRATED THE PATIENT'S DIAPHRAGM AND PLEURA THEREBY CONTRIBUTING TO THE INFECTION. NO ESOPHAGEAL PERFORATION WAS EVIDENCED. INVESTIGATION: INSPECTION OF RETURNED PRODUCT: NO PRODUCT WAS RETURNED FROM THIS CASE AND THEREFORE NO PRODUCT INSPECTION WAS POSSIBLE. THERE WAS NO REPORTED PRODUCT MALFUNCTION IN THIS CASE. CASE REVIEW: THIS WAS ONE OF TWO INITIAL PLICATOR TREATMENT CASES PERFORMED BY DR. PARK AND THE CASE WAS PROCTORED BY AN NDO SURGICAL CLINICAL APPLICATIONS SPECIALIST. THERE WERE NO REPORTS OF PRODUCT MISUSE DURING THE PATIENT TREATMENT PORTION OF THIS CASE. THERE WAS NO PRODUCT MALFUNCTION IN THIS CASE. PRIOR TO THE CASE, THE PLICATOR INSTRUMENT WAS CLEANED AND MANUALLY DISINFECTED VIA AN ALCOHOL SOAK. THIS IS DIFFERENT THAN THE DISINFECTION METHOD RECOMMENDED BY PLICATOR LABELING BUT WAS THE OPTION CHOSEN BY THE HOSPITAL BASED ON THE FACT THAT THEY DID NOT HAVE GLUTARALDEHYDE DISINFECTANT SOLUTIONS ON HAND. DEVICE HISTORY RECORD (DHR) RESULTS: THE DEVICE HISTORY RECORDS FOR THE PLICATOR IMPLANT (LOT # 07-0005) AND TISSUE RETRACTOR (LOT # 06-0053) USED IN THIS CASE WERE REVIEWED. IMPLANT LOT # 07-0005 WAS COMPRISED OF 200 UNITS AND WAS MANUFACTURED AND PACKAGED ON APRIL 2, 2007. THE LOT WAS SUBSEQUENTLY STERILIZED AS NSI 074001 AND RELEASED TO FINISHED GOODS ON APRIL 26, 2007. THERE WERE NO ANOMALIES NOTED FOR THE STERILIZATION PROCESS FOR THIS COMPONENT. THE LOT WAS REWORKED UNDER IRR # 4471 ON JULY 12, 2007 TO INSERT A NEW VERSION IFU IN THE UNIT PACKAGE; THE REWORK HAD NO IMPACT ON PRODUCT STERILITY. TISSUE RETRACTOR LOT # 06-0053 WAS COMPRISED OF 200 UNITS AND WAS MANUFACTURED AND PACKAGED ON DECEMBER 4, 2006. THE LOT WAS SUBSEQUENTLY STERILIZED AS NSI 064007 AND RELEASED TO FINISHED GOODS ON DECEMBER 13, 2006. THERE WERE NO ANOMALIES NOTED FOR THE STERILIZATION PROCESS FOR THIS COMPONENT. THE LOT WAS REWORKED UNDER IRR # 4471 ON JULY 12, 2007 TO INSERT A NEW VERSION IFU IN THE UNIT PACKAGE; THE REWORK HAD NO IMPACT ON PRODUCT STERILITY. THERE WAS NOTHING ABNORMAL OR THAT COULD HAVE CONTRIBUTED TO THIS ISSUE IN EITHER THE IMPLANT OR TISSUE RETRACTOR DHR'S. COMPLAINT LOG & AE DATABASE REVIEW: A REVIEW OF THE COMPLAINT LOG AND ADVERSE EVENT DATABASE REVEALED THE PRESENCE OF SPORADIC REPORTS OF ELEVATED C-REACTIVE PROTEIN, LEUCOCYTOSIS, PNEUMONIA AND PLEURAL EFFUSION. PLICATOR IFU LABELING LISTS INFECTION, PNEUMONIA AND PLEURAL EFFUSION AS ANTICIPATED POTENTIAL COMPLICATIONS. THIS IS THE FIRST SPECIFIC REPORT OF EMPYEMA. CONCLUSIONS: THERE IS NO OBVIOUS MISUSE AND NO PRODUCT MALFUNCTION REPORTED IN THIS CASE. IT IS UNCLEAR WHETHER THE PRE-PROCEDURE HIGH LEVEL DISINFECTION PROTOCOL USED BY THE SITE CONTRIBUTED TO THE PATIENT'S INFECTION. HOWEVER, THE TIMING OF EVENT ONSET AND THE "OBSERVATION" THAT PLICATOR NEEDLES PENETRATED THE PATIENT'S DIAPHRAGM AND PLEURA STRONGLY IMPLICATES THE PLICATOR TREATMENT AS A CASUAL AGENT IN THIS INCIDENT. CORRECTIVE ACTION: PRE-TREATMENT DISINFECTION TECHNIQUES WILL BE REVIEWED WITH DR. AND HIS STAFF AS PART OF THE SITE'S ONGOING TRAINING PROCESS. VALIDATED DISINFECTION METHODS WILL BE USED FOR THE PLICATOR INSTRUMENT IN ADVANCE OF THE NEXT TREATMENT CASES BEING PERFORMED BY DR.'S SITE. THERE WAS NO PRODUCT MALFUNCTION AND NO APPARENT PRODUCT MISUSE IN THIS CASE. INFECTION IS LISTED AS A POTENTIAL COMPLICATION OF PLICATOR THERAPY IN THE PRODUCT'S IFU. ACCORDINGLY, NO CORRECTIVE ACTION WILL BE IMPLEMENTED AT THIS TIME.

    Description of Event or Problem · 1

    A MALE PATIENT WITH A HISTORY OF NON-ACID REFLUX DUE TO A PREVIOUS VAGOTOMY DEVELOPED EMPYEMA IN THE LEFT PLEURA TWO DAYS POST-PLICATOR TREATMENT. THE PATIENT UNDERWENT A THORACOTOMY TO TREAT THE EMPYEMA AND SUBSEQUENTLY, RECOVERED WITHOUT FURTHER INCIDENT. THE PHYSICIAN WHO PERFORMED THE THORACOTOMY FELT THAT ONE OF THE PLICATOR SUTURES SEEMED TO PASS THROUGH THE DIAPHRAGM AND INTO THE PLEURAL SAC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLICATOR ENDOSCOPE/ACCESSORY KOG NDO SURGICAL, INC. 160-01130 07-0005

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R