BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIOPSY FORCEPS

    MDR report key: 12305648 · Received August 11, 2021

    Report

    Report Number
    8010047-2021-10056
    Event Type
    Death
    Date Received
    August 11, 2021
    Report Date
    August 11, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    PMA / PMN Number
    K962555
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. SINCE THE LOT NUMBER IS UNKNOWN, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. HOWEVER, OMSC HAS ONLY SHIPPED DEVICES THAT PASSED THE INSPECTION. IN THE LITERATURE, THERE WAS NO DESCRIPTION OF THE DEVICE'S MALFUNCTION.

    Description of Event or Problem · 1

    ON JULY 26 OMSC RECEIVED THE LITERATURE "DIAGNOSTIC YIELD, SAFETY, AND IMPACT OF TRANSBRONCHIAL LUNG BIOPSY IN MECHANICALLY VENTILATED, CRITICALLY ILL PATIENTS: A RETROSPECTIVE STUDY". THE PURPOSE OF THE LITERATURE WAS TO ASSESS THE DIAGNOSTIC YIELD, SAFETY, AND THERAPEUTIC CONSEQUENCES OF TRANSBRONCHIAL LUNG BIOPSY IN A COHORT OF MECHANICALLY VENTILATED, CRITICALLY ILL PATIENTS. THE PROCEDURE WAS PERFORMED USING BIOPSY FORCEPS (OLYMPUS), CRYOPROBE (NON-OLYMPUS), SMOOTHBORE CONNECTOR (NON-OLYMPUS), ENDOTRACHEAL TUBE OR TRACHEAL CANNULA (MANUFACTURER UNKNOWN), AND A BRONCHOSCOPE (OLYMPUS). EXPLORATORY, RETROSPECTIVE, MONOCENTRIC, OBSERVATIONAL STUDY ON MECHANICALLY VENTILATED, CRITICALLY ILL PATIENTS, TREATED AT THE SCHILLERHOEHE LUNG CLINIC (GERLINGEN, GERMANY) FROM JANUARY 2014 TO JULY 2019, AND SUBJECTED TO TRANSBRONCHIAL LUNG BIOPSY DUE TO UNEXPLAINED PULMONARY INFILTRATES. FORTY-TWO PATIENTS WITH IN TOTAL 42 TBLB PROCEDURES WERE ASSESSED, OF WHICH SEVEN PATIENTS (16.7%) WERE IMMUNOSUPPRESSED, BUT THERE WAS NO PATIENT WITH PRIOR LUNG TRANSPLANTATION. IN THE LITERATURE, IT WAS REPORTED 3 CASES OF PNEUMOTHORAX, 3 CASES OF MINOR BLEEDING, AND 1 CASE OF HEMODYNAMIC INSTABILITY WITH SHOCK AND DEATH. THE LITERATURE WROTE ABOUT OTHER COMPLICATIONS AS BELOW. ¿PNEUMOTHORAX, OCCURRING IN THREE PATIENTS (7.1%) WHO ALL REQUIRED A CHEST DRAINAGE, WAS AMONGST THE MOST COMMON ADVERSE EVENT. HOWEVER, TRANSBRONCHIAL LUNG BIOPSY (TBLB) WAS PERFORMED WITH CHEST DRAINAGE PROTECTION IN 18 PATIENTS, SO THAT FREQUENCY INCREASED TO 12.5% WHEN PNEUMOTHORACES WERE RELATED TO PATIENTS WITHOUT SUCH A PROTECTION. ONE PNEUMOTHORAX OCCURRED AFTER CRYOBIOPSY AND THE OTHERS OCCURRED AS A RESULT OF FORCEPS BIOPSY, BUT NO PATIENT DEVELOPED A PERSISTENT AIR LEAK. BIOPSIES LEADING TO PNEUMOTHORAX WERE PERFORMED IN THE RIGHT UPPER LOBE/ RIGHT LOWER LOBE (RLL) (TWICE) AND IN THE RLL (ONCE). MINOR BLEEDING OCCURRED IN 7.1%, BUT THERE WAS NO MAJOR BLEEDING EVENT. ONE PATIENT DIED AS RESULT OF FORCEPS BIOPSY WITH TENSION PNEUMOTHORAX AND PERSISTENT HEMODYNAMIC INSTABILITY WITH SHOCK DESPITE IMMEDIATE CHEST TUBE INSERTION.¿ THE OLYMPUS MEDICAL LICENSED PERSONS REVIEWED ABOUT A CASE OF THE DEATH AFTER DEVELOPING A TENSION PNEUMOTHORAX AND PERSISTENT HEMODYNAMIC INSTABILITY WITH SHOCK AS FOLLOWS. ¿IN THIS CASE, THE BIOPSY WAS PERFORMED WITH FORCEPS IN A HIGH RISK CONDITION TO BEGIN WITH. IN THE CONCLUSION, IT CAN BE INFERRED THAT THE SURGEON WAS AWARE OF THE RISKS AND PERFORMED THE PROCEDURE. "THE COMPLICATION RATE IS LOW, ALTHOUGH SERIOUS AND FATAL ADVERSE EVENTS CAN'T BE COMPLETELY EXCLUDED, WHICH MUST BE WEIGHED AGAINST THE LIMITED THERAPEUTIC CONSEQUENCE AND THE APPARENT LACK OF BENEFIT IN SURVIVAL IN PATIENTS WITH A CHANGE IN TREATMENT BASED ON THE HISTOPATHOLOGICAL RESULT." HOWEVER, "ONE PATIENT DIED AS A RESULT OF FORCEPS BIOPSY WITH TENSION PNEUMOTHORAX AND PERSISTENT HEMODYNAMIC INSTABILITY WITH SHOCK DESPITE IMMEDIATE CHEST TUBE INSERTION" AND THE TIME LINE SUGGEST A RELATIONSHIP WITH THE PROCEDURE, AS DISCUSSED IN THE LITERATURE. IN ADDITION, THE ASSOCIATION BETWEEN THE DEVICE AND THE CAUSE OF DEATH CANNOT BE COMPLETELY RULED OUT AT PRESENT, WHEN NO INFORMATION ON DEVICE FAILURE IS AVAILABLE.¿ BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE OLYMPUS PRODUCT AND THESE COMPLICATIONS MIGHT BE DETERMINED. HOWEVER, A CASE OF THE DEATH AFTER DEVELOPING A TENSION PNEUMOTHORAX AND PERSISTENT HEMODYNAMIC INSTABILITY WITH SHOCK MIGHT BE ASSOCIATED WITH THE OLYMPUS BIOPSY FORCEPS. THIS IS THE REPORT REGARDING A CASE OF THE DEATH AFTER DEVELOPING A TENSION PNEUMOTHORAX AND PERSISTENT HEMODYNAMIC INSTABILITY WITH SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1204927 BIOPSY FORCEPS EOQ OLYMPUS MEDICAL SYSTEMS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death