PLASMABLADE 4.0 GENERAL SURGERY
Report
- Report Number
- 1226420-2014-00073
- Event Type
- Injury
- Date Received
- August 22, 2014
- Date of Event
- July 24, 2014
- Report Date
- September 30, 2014
- Manufacturer
- MEDTRONIC ADVANCED ENERGY, LLC
- Product Code
- DWG
- PMA / PMN Number
- K073057
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
PRODUCT EVENT #(B)(4) TESTING PERFORMED: DEVICE PACKAGING INSPECTION: DEVICE RETURNED IN A PADDED (B)(6) MAILER ENVELOPE WITH NO PACKAGING TO FILL THE NEGATIVE SPACE WITHIN A SINGLE BIOHAZARD BAG AND DOUBLE BAGGED WITHIN BIOHAZARD BAGS. TYVEK® LID, AND DEVICE HOLSTER WAS INCLUDED; THE DEVICE INFORMATION WAS CONFIRMED AGAINST THE INFORMATION THAT IS LISTED IN THE PRODUCT EVENT PAGE IN GCH. RGA E-MAIL WITH DEVICE RETURN INSTRUCTIONS INCLUDED DEVICE VISUAL INSPECTION: DEVICE IS USED WITH TISSUE AND ESCHAR BUILD-UP ON THE ELECTRODE AND CHARRING OF THE ELECTRODE. BLOOD ON BODY, HANDLE, AND CORD. ALL COMPONENTS APPEAR IN PLACE, INTACT WITH NO DAMAGE. THERE ARE NO VISUAL SIGNS RELATED TO THE COMPLAINT DESCRIPTION. BOTH CUT AND COAG BUTTONS HAVE A DEFINITIVE TACTILE FEEL. FUNCTIONAL INSPECTION: THE PLASMABLADE¿ 4.0 WAS CONNECTED TO THE COMPLAINT LAB PULSAR® II GENERATOR AND THE EXPECTED E5 ERROR CODE, END OF LIFE, WAS DISPLAYED INDICATING THAT THE DEVICE HAD BEEN SUCCESSFULLY ACTIVATED AND CONNECTED TO A PULSAR® II GENERATOR PREVIOUSLY. THE DEVICE WAS TESTED FOR FUNCTIONALITY, PER 42-10-1020 REV. C; THE DEVICE WAS ACTIVATED IN GROUNDED SALINE IN THE COLLAPSED POSITION, AT CUT SETTING¿2 AND COAG SETTING-1, SETTINGS USED FOR TESTING DURING MANUFACTURING, WITH ACCEPTABLE RESULTS. ¿THE DEVICE IS ACCEPTABLE IF THE ¿GLOW¿ AROUND THE EDGE OF THE BLADE IS OBSERVED AND AN AUDIBLE HIGH PITCH NOISE IS HEARD COMING FROM THE GENERATOR WHEN BOTH BUTTONS CUT AND COAG ARE ACTUATED¿, WHICH WAS OBSERVED DURING FUNCTIONAL INSPECTION OF THE COMPLAINT DEVICE. LHR REVIEW: A REVIEW OF THE LHR FOR LOT # FL50802970 REVEALED THAT THERE WERE NO PROBLEMS DURING MANUFACTURING THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. INVESTIGATION CONCLUSION: THE COMPLAINT IS NOT CONFIRMED FOR THE ¿4.0 - INTERFERENCE ¿ PACEMAKER¿ ISSUE. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN GROUNDED SALINE AND MET THE PRODUCT SPECIFICATIONS WITH ACCEPTABLE RESULTS. THE DEVICE RESPONDED NORMALLY WHEN CONNECTED TO THE PULSAR® II GENERATOR FOR ALL ACTIVATION SETTINGS. NO FAILURES WERE FOUND. IT CANNOT BE DETERMINED WHETHER THERE IS INTERFERENCE SPECIFICALLY WITH WAVEFORM FUNCTIONALITY OF THE ST. JUDE PACEMAKER. THE PLASMABLADE¿ 4.0 DEVICE IS IN COMPLIANCE PER, 81-10-0275 REV. A ¿ IEC TESTING PLASMABLADE¿ 4.0. ELECTROMAGNETIC INTERFERENCE DUE TO INADEQUATE OR INSUFFICIENT SHIELDING OR GROUNDING OR FILTERING OF THE ST. JUDE PACEMAKER IS A PLAUSIBLE CAUSE OF WAVEFORM INTERFERENCE. MEDTRONIC ADVANCED ENERGY COMPLIES WITH SAFETY AND EFFECTIVENESS OF MEDICAL ELECTRICAL EQUIPMENT REQUIREMENTS ACCORDING TO IEC 60601-1:2005 (3RD ED.), IEC 60601-2-2: (5THED.). IN ADDITION, ST. JUDE HAS RELEASED A LETTER STATING THAT CERTAIN MODELS OF ST. JUDE PACEMAKERS, WHEN UTILIZED IN CONJUNCTION WITH ELECTROCAUTERY, MAY BE FUNCTIONALLY AFFECTED. NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. THE COMPLAINT WILL BE MONITORED IN GCH FOR FUTURE INSTANCES. HTTP://PROFESSIONAL.SJM.COM/PROFESSIONAL/RESOURCES/PRODUCT-PERFORMANCE/P ACEMAKER-012914-COMMUNICATION/PHYSICIAN-COMMUNICATION PATIENT CODES : C25637 DEVICE CODES : C63214
(B)(4). EVAL METHOD: PRODUCT RECEIVED BY MANUFACTURER AND PENDING INSPECTION. EVAL RESULTS: PRODUCT RECEIVED BY MANUFACTURER AND PENDING INSPECTION. EVAL CONCLUSION: PRODUCT RECEIVED BY MANUFACTURER AND PENDING INSPECTION. (B)(4).
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
DURING A PACEMAKER GENERATOR EXCHANGE PROCEDURE, THE PLASMABLADE WAS ACTIVATED AND THE PACEMAKER PACING OUTPUT WAS REDUCED TO 30BPM, THEREFORE, PATIENT HR WAS REDUCED TO 30BPM. PLASMABLADE ACTIVATION WAS CEASED AND AFTER APPROXIMATELY 30-40 SECONDS, THE PACEMAKER OUTPUT AND PATIENT'S HR RETURNED TO A NORMAL RATE OF 60 BPM (PATIENT IS PACEMAKER DEPENDENT). TEMPORARY PACING WAS AVAILABLE BUT NOT UTILIZED AS PACEMAKER OUTPUT AND PATIENT HR RECOVERED BEFORE THE TEMPORARY SYSTEM COULD BE UTILIZED (30-40 SECONDS). SURGEON USED THE PLASMABLADE AGAIN AFTER THE NEW ST. JUDE PACEMAKER WAS IMPLANTED AND ACTIVATION OF THE PLASMABLADE DID NOT IMPACT PACEMAKER FUNCTIONALITY. ST. JUDE IDENTITY WAS THE PACEMAKER INVOLVED IN THE REPORTED INCIDENT. ST JUDE HAS RELEASED A DOCUMENT STATING THAT ELECTROSURGERY MAY HAVE AN IMPACT TO THE FUNCTIONALITY OF OLDER MODEL ST. JUDE PACEMAKERS AND RECOMMENDS NO ELECTROSURGERY DEVICES TO BE USED. REFERENCE LINK: HTTP://PROFESSIONAL.SJM.COM/PROFESSIONAL/RESOURCES/PRODUCT-PERFORMANCE/PACEMAKER-012914-COMMUNICATION/PHYSICIAN-COMMUNICATION.
DURING A PACEMAKER GENERATOR EXCHANGE PROCEDURE THE PLASMABLADE WAS ACTIVATED AND THE PACEMAKER PACING OUTPUT WAS REDUCED TO 30BPM, THEREFORE PATIENT HR WAS REDUCED TO 30BPM. PLASMABLADE ACTIVATION WAS CEASED AND AFTER APPROXIMATELY 30-40 SECONDS THE PACEMAKER OUTPUT AND PATIENT'S HR RETURNED TO A NORMAL RATE OF 60 BPM (PATIENT IS PACEMAKER DEPENDENT). TEMPORARY PACING WAS AVAILABLE BUT NOT UTILIZED AS PACEMAKER OUTPUT AND PATIENT HR RECOVERED BEFORE THE TEMPORARY SYSTEM COULD BE UTILIZED (30-40 SECONDS). SURGEON USED THE PLASMABLADE AGAIN AFTER THE NEW ST. JUDE PACEMAKER WAS IMPLANTED AND ACTIVATION OF THE PLASMABLADE DID NOT IMPACT PACEMAKER FUNCTIONALITY. ST. JUDE IDENTITY WAS THE PACEMAKER INVOLVED IN THE REPORTED INCIDENT. ST JUDE HAS RELEASED A DOCUMENT STATING THAT ELECTROSURGERY MAY HAVE AN IMPACT TO THE FUNCTIONALITY OF OLDER MODEL ST. JUDE PACEMAKERS AND RECOMMENDS NO ELECTROSURGERY DEVICES TO BE USED. REFERENCE LINK: HTTP://PROFESSIONAL.SJM.COM/PROFESSIONAL/RESOURCES/PRODUCTPERFORMANCE/ PACEMAKER-012914-COMMUNICATION/PHYSICIAN-COMMUNICATION
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 508121 | PLASMABLADE 4.0 GENERAL SURGERY | ELECTROSURGICAL DEVICE | DWG | MEDTRONIC ADVANCED ENERGY, LLC | PS200-040 | FL50802970 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00083 YR |