BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE 4.0 GENERAL SURGERY

    MDR report key: 3769053 · Received April 24, 2014

    Report

    Report Number
    1226420-2014-00033
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 27, 2014
    Report Date
    May 1, 2014
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    DWG
    PMA / PMN Number
    K082786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) METHOD, RESULTS AND CONCLUSIONS: PRODUCT RECEIVED BY MANUFACTURER AND PENDING INSPECTION. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT #(B)(4). TESTING PERFORMED: DEVICE: PLASMABLADE¿ 4.0 PRODUCT CODE (SKU): UNKNOWN SERIAL / LOT NUMBER: UNKNOWN EXPIRATION DATE: UNKNOWN QUANTITY RETURNED: 1 NO ORIGINAL PACKAGING WAS INCLUDED WITH THE RETURNED DEVICE; THEREFORE IT IS NOT POSSIBLE TO CONFIRM THE DEVICE THAT WAS SENT BACK AS THE REPORTED COMPLAINT DEVICE. LOT NUMBER AND EXPIRATION DATE ARE LISTED AS ¿UNKNOWN¿ IN GCH. PRODUCT SKU WAS OBTAINED FROM THE PRODUCT LINE ITEM IN GCH. PRODUCT CODE (SKU): PS200-040 VISUAL INSPECTION (PACKAGING): THE PRODUCT WAS SHIPPED IN A PROPER SHIPPING CONTAINER. THERE WAS NO PACKAGING TO FILL NEGATIVE SPACE. THE DEVICE WAS NOT SAFETY PACKAGED. THERE WAS NO ADDITIONAL PAPERWORK INCLUDED. VISUAL INSPECTION (PRODUCT): THERE WAS EVIDENCE OF USE; DEVICE CORD WITH PLUG HAS BEEN CUT FROM THE DEVICE, DEVICE SHAFT HAD BEEN BENT, AND THERE WAS ESCHAR AND CHARRING OF THE ELECTRODE.. THERE WAS EVIDENCE OF DAMAGE; DEVICE CORD WITH PLUG HAS BEEN CUT FROM THE DEVICE, HEAT SHRINK IS SPLIT, PULLED BACK FROM THE DEVICE WITH ESCHAR BUILD UP UNDERNEATH THE HEAT SHRINK. THE BUTTON DOES HAVE TACTILE FEEL. THERE ARE VISUAL SIGNS RELATED TO THE COMPLAINT DESCRIPTION; HEAT SHRINK IS SPLIT, PULLED BACK FROM THE DEVICE WITH ESCHAR BUILD UP UNDERNEATH THE HEAT SHRINK. FUNCTIONAL INSPECTION: FUNCTIONAL INSPECTION IS NOT POSSIBLE SINCE THE DEVICE CORD WITH PLUG CONNECTOR HAS BEEN CUT OFF FROM THE DEVICE. LHR REVIEW: THE LOT # IS LISTED IN GCH AS UNKNOWN AND THERE WAS NO ORIGINAL PACKAGING RETURNED WITH THE REPORTED COMPLAINT DEVICE, THEREFORE IT IS NOT POSSIBLE TO PERFORM AN LHR REVIEW. INVESTIGATION CONCLUSION: THE COMPLAINT WAS CONFIRMED AND FOUND TO BE OUT OF PRODUCT SPECIFICATION FOR THE ¿SHAFT MELT ¿ PULLED BACK FROM SHAFT¿ ISSUE THAT WAS REPORTED IN THE COMPLAINT DESCRIPTION. THE HEAT SHRINK APPEARED TO HAVE SPLIT AT THE NECK OF THE BLADE LIKELY AS A RESULT OF THERMAL DAMAGE DURING USE IN CONJUNCTION WITH A HEAT SHRINK HAD BEEN COMPROMISED. DURING VISUAL INSPECTION IT WAS NOTED THAT THE HEAT SHRINK HAD ESCHAR BUILD-UP INSIDE THE AREA THAT WAS SPLIT. IT IS PLAUSIBLE TO SUGGEST THAT DURING CUSTOMER USE AND PROBABLE MISUSE, SEE IFU WARNINGS LISTED BELOW, OF THE DEVICE THAT THE ESCHAR BUILD-UP EXPERIENCED EXTREME HEAT AND CAUSED ENERGY TO BE CENTRALIZED AT THE HEAT SHRINK AREA CAUSING IT SHRINK, SPLIT AND LOSE ITS INTEGRITY. THE PURPLE LINES ON THE LCD DISPLAY ON THE GENERATOR AT THE CUSTOMER SITE THAT WAS DESCRIBED IN THE REPORTED COMPLAINT COULD NOT BE REPRODUCED IN THE COMPLAINT LAB ENVIRONMENT AND IS LIKELY ISOLATED TO THE GENERATOR LOCATED AT THE CUSTOMER SITE AND IS BEYOND THE SCOPE OF THIS COMPLAINT INVESTIGATION. THE HEAT SHRINK REMAI NED ATTACHED TO THE SHAFT BENEATH THE FINGER GRIP. PLASMABLADE¿ 4.0 ¿ IFU ¿ LBL-00116 REV. B ¿ WARNINGS WHEN BENDING THE PEAK PLASMABLADE SHAFT, DO NOT EXCEED A 45° ANGLE WITH THE PLANE OF THE SHAFT. DO NOT BEND MORE THAN THREE TIMES. BEND THE SHAFT, NOT THE TIP. EXCESSIVE BENDING OF THE SHAFT MAY COMPROMISE PERFORMANCE OF THE DEVICE OR CAUSE DEVICE FAILURE, WHICH COULD RESULT IN PATIENT OR USER INJURY. USE FINGER FORCE TO SHAPE THE SHAFT; DO NOT USE FORCEPS AS THIS COULD DAMAGE THE DEVICE. USE THE LOWEST POWER SETTING AND THE SHORTEST ACTIVATION TIME POSSIBLE TO ACHIEVE THE DESIRED END EFFECT. UNLESS THE PRODUCT IS BEING USED TO SPOT COAGULATE A VESSEL, IT IS RECOMMENDED TO KEEP THE ELECTRODE TIP IN MOTION WHILE ACTIVATED TO AVOID EXCESSIVE ESCHAR BUILDUP. EXCESSIVE ESCHAR BUILDUP CAN COMPROMISE DEVICE PERFORMANCE. DUE TO THE LOW OCCURRENCE OF THIS FAILURE MODE, THIS COMPLAINT WILL BE MONITORED IN GCH FOR FURTHER INSTANCES OF SIMILAR COMPLAINTS. REFERENCED DOCUMENTS: 42-10-102 REV. B ¿ WORK INSTRUCTIONS FOR COMPLAINT INVESTIGATIONS ¿ DISPOSABLE DEVICES LBL-00116 REV. B ¿ PLASMABLADE¿ 4.0 ¿ IFU ¿ INSTRUCTIONS FOR USE PD-00001 REV. B ¿ PLASMABLADE¿ 4.0 ¿ PRODUCT PERFORMANCE SPECIFICATION(B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DURING USE IN A CASE IT WAS NOTED THAT THE HEAT SHRINK ON THE PLASMABLADE 4.0'S BENDABLE SHAFT STARTED TO MELT, SPLIT, AND BEGAN TO PULL AWAY FROM THE DEVICE SHAFT. THIS OCCURRED APPROXIMATELY 30 MINUTES INTO THE CASE AND DEVICE WAS REPLACED WITH AN ADDITIONAL ONE TO ALLOW FOR THE CASE TO PROCEED. NO PATIENT IMPACT.

    Description of Event or Problem · 1

    DURING USE IN A CASE IT WAS NOTED THAT THE HEAT SHRINK ON THE PLASMABLADE 4.0'S BENDABLE SHAFT STARTED TO MELT, SPLIT, AND BEGAN TO PULL AWAY FROM THE DEVICE SHAFT. THIS OCCURRED APPROXIMATELY 30 MINUTES INTO THE CASE AND DEVICE WAS REPLACED WITH AN ADDITIONAL ONE TO ALLOW FOR THE CASE TO PROCEED. NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249237 PLASMABLADE 4.0 GENERAL SURGERY ELECTROSURGICAL DEVICE DWG MEDTRONIC ADVANCED ENERGY, LLC PS200-040 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1