BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL* BLADELESS TROCAR WITH STABILITY SLEEVE

    MDR report key: 1770620 · Received July 27, 2010

    Report

    Report Number
    3005075853-2010-04218
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    July 7, 2010
    Report Date
    July 14, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.(B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). A CONFERENCE CALL WITH EES MARKETING, QUALITY, R&D, THE SALES REP, AND DM OCCURRED. THE CALL TOOK PLACE TO DISCUSS THE RECENT INSUFFLATION ISSUE COMPLAINTS AT THE ACCOUNT. THE CONVERSATION INCLUDED DISCUSSION ON TORQUING ISSUES, LEAK WITH NO SCOPE OR INSTRUMENT, AND LEAK WITH A 5MM INSTRUMENT/SCOPE IN A TROCAR. SURGEONS HAVE MITIGATED THE EVENTS BY ADDED A SECOND INSUFFLATORS OR OBTAINING A NEW TROCAR TO COMPLETE THE CASE. IN ADDITION, EES ASSOCIATES MET WITH THIS SURGEON TO DISCUSS HIS ISSUE. THE SURGEON EXPRESSED HIS MAIN CONCERNS HAVE BEEN WITH THE H12LP TROCAR AS THIS IS USED AS THE PRIMARY SCOPE PORT AND FOR WHEN LARGE DEVICES ARE REQUIRED. HIS OTHER OPERATIVE PORTS ARE ALL 5MM. HE NOTICED THE TROCARS STARTED LEAKING WHEN TORQUING THE DEVICE WITH A 5MM SCOPE OR OTHER 5MM DEVICES. THE UNIQUE PART OF THE DISCUSSION WITH THE SURGEON WAS THAT WHILE THE LEAKING WAS OCCURRING WHEN THE TROCAR WAS BEING TORQUE, HE DID NOT BELIEVE THE LEAK WAS COMING FROM UNDER THE UNIVERSAL SEAL CAP, BUT RATHER, THROUGH THE PACMAN SEAL. EVIDENCE FOR THIS CONCLUSION IS BASED ON BEING ABLE TO FEEL THE GAS LEAK IMPINGE ON HIS HAND AND ALSO BEING ABLE TO SEE A SMALL TRIANGLE OF LIGHT THROUGH THE SEAL WHEN BEING TORQUE (PARTICULARLY WHEN THE SCOPE IS IN THIS PORT).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THERE WAS PNEUMO HISSING. AN INSTRUMENT WAS INSERTED INTO THE DEVICE, BUT IT WAS NOT TORQUED. THEY SWITCHED IT OUT AND COMPLETED THE PROCEDURE WITHOUT IMPACT TO THE PATIENT.

    Description of Event or Problem · 1

    ON (B)(6), 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT HIS ONETOUCH ULTRA METER WAS DISPLAYING AN UNSPECIFIED ERROR MESSAGE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) REVIEWED THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION AND SPOKE WITH THE PATIENT ON (B)(6), 2010 TO CLASSIFY THIS CASE.THE PATIENT ALLEGED THAT THE PRODUCT ISSUE BEGAN AT APPROXIMATELY 8:00 PM ON (B)(6), 2010 WHILE HE WAS STAYING IN (B)(6). THE PATIENT STATED THAT THE ONETOUCH ULTRA METER WAS HIS BACK-UP METER. IT IS NOT KNOWN WHEN THE PATIENT HAD TESTED LAST AND WHAT READINGS HE WAS OBTAINING FROM THE ALLEGED METER PRIOR TO WHEN THE ISSUE STARTED. THE CSR DOCUMENTED THAT THE PATIENT MANAGES HIS DIABETES WITH HUMALOG INSULIN (NO ADJUSTMENTS). THE PATIENT REPORTED THAT DUE TO THE ALLEGED ISSUE, HE SKIPPED USUAL DOSE OF INSULIN (6 UNITS) AT 8:00 PM ON (B)(6), 2010. A FEW MINUTES AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT CLAIMED THAT HE "FELT LIKE PASSING OUT." THE PATIENT STATED THAT HE LIED DOWN AND WHEN THE SYMPTOM DID NOT DISAPPEAR, HE CALLED A DOCTOR TO COME TO HIS HOUSE. THE PATIENT STATED THAT THE DOCTOR ARRIVED IN HIS HOME AT APPROXIMATELY 10:00 PM ON (B)(6), 2010. THE PATIENT'S BLOOD GLUCOSE WAS REPORTEDLY TESTED ON THE DOCTOR'S METER AND OBTAINED A RESULT OF "3.5 MMOL/L." THE PATIENT REPORTED THAT THE DOCTOR TREATED HIM WITH A GLUCOSE TABLET. DURING THE TROUBLESHOOTING, THE CSR DOCUMENTED THAT THE PATIENT DID NOT HAVE THE METER OR THE STRIPS AT THE TIME OF THE CALL. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING CLASSIFIED AS MDR-REPORTABLE DUE TO THE FOLLOWING CONCLUSION(S): THE PATIENT CLAIMS HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE ALLEGED ISSUE, REPORTEDLY BECAME FAINT, AND RECEIVED ACUTE MEDICAL TREATMENT FROM A DOCTOR AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** XCEL* BLADELESS TROCAR WITH STABILITY SLEEVE LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1