BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 14228018 · Received April 27, 2022

    Report

    Report Number
    2955842-2022-11269
    Event Type
    Injury
    Date Received
    April 27, 2022
    Report Date
    March 31, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    PMA / PMN Number
    K183224
    Removal / Correction Number
    ISIFA2022-02-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE PATIENT¿S POST-OPERATIVE COMPLICATION CANNOT BE DETERMINED. ISI HAS ATTEMPTED TO CONTACT THE SITE TO GATHER ADDITIONAL INFORMATION REGARDING THE PATIENT/INCIDENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO NEW INFORMATION HAS BEEN OBTAINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. UNABLE TO PERFORM SYSTEM OR INSTRUMENT LOGS REVIEW WITH THE LACK OF PRODUCT AND PROCEDURE INFORMATION ON FILE AT THE TIME. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, THE PATIENT EXPERIENCED A POST-OPERATIVE AIR LEAK MORE THAN 7 DAYS AFTER THE PROCEDURE. THE AIR LEAK ALLEGEDLY OCCURRED FROM THE BRONCHUS AFTER USING THE SUREFORM 45 STAPLER INSTRUMENT WITH AN UNSPECIFIED RELOAD COLOR. BASED ON THE INFORMATION AVAILABLE, THE CAUSE OF THE POST-OPERATIVE AIR LEAK IS UNKNOWN. ALTHOUGH THE PATIENT WAS ADMITTED TO INTENSIVE CARE DUE TO THE POST-OPERATIVE COMPLICATION, IT IS ALSO UNKNOWN WHAT SPECIFIC MEDICAL INTERVENTION WAS ADMINISTERED FOR THE AIR LEAK. FOLLOW-UP WAS ATTEMPTED, BUT THE MISSING PATIENT INFORMATION IN SECTIONS WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION IS NOT APPLICABLE. FIELD IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION IS NOT AVAILABLE. FIELDS ARE NOT APPLICABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU). THE PATIENT REPORTEDLY SUFFERED FROM A POST-OPERATIVE AIR LEAK. ACCORDING TO THE SURGEON, THE AIR LEAK OCCURRED FROM THE BRONCHUS AFTER USING THE SUREFORM 45 STAPLER AND POTENTIALLY THE FORCE FIRE FUNCTION. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION: THE AIR LEAK OCCURRED MORE THAN 7 DAYS AFTER THE LOBECTOMY PROCEDURE. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1530336 SUREFORM SUREFORM 45 RELOAD GDW INTUITIVE SURGICAL, INC 48345 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DA VINCI INSTRUMENTS AND ACCESSORIES