PLASMABLADE 3.0S
Report
- Report Number
- 1226420-2016-00139
- Event Type
- Malfunction
- Date Received
- September 30, 2016
- Date of Event
- September 1, 2016
- Report Date
- October 13, 2016
- Manufacturer
- MEDTRONIC ADVANCED ENERGY, LLC
- Product Code
- GEI
- PMA / PMN Number
- K093695
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
(B)(4): BRIEF DESCRIPTION OF COMPLAINT: THE ELECTRODE COATING WAS PEELING AND THEN THE PLASMABLADE DID NOT WORK ANY ANYMORE. ANOTHER DEVICE WAS TRIED AND AFTER MINUTES, THE SAME ISSUE OCCURRED. INVESTIGATION PLAN: VISUAL INSPECTION FUNCTIONAL INSPECTION (IF APPLICABLE) LHR REVIEW COMPLAINT DEVICE DETAILS: DEVICE NAME: PLASMABLADE 3.0S, PRODUCT NUMBER: PS210-030S ,LOT NUMBER: 0210643118, EXPIRATION DATE: 11-SEP-2019, QUANTITY RETURNED: 2 VISUAL INSPECTION: TESTING PERFORMED: DEVICE PACKAGING INSPECTION: TWO RETURNED PLASMABLADE 3.0S DEVICES WITH LOCKING MECHANISM WERE RECEIVED INSIDE A CARDBOARD BOX WITHIN A SEALED AUTOCLAVE BAG WITH NO PACKAGING TO FILL THE NEGATIVE SPACE. THE DISPLAY BOX WAS RETURNED; THERE IS A PRODUCT RETURN DISCREPANCY AS THE LOT NUMBER DOES NO MATCH THE POPULATED PLI INFORMATION LISTED WITHIN GCH, THEREFORE, IT IS NEITHER POSSIBLE TO CONFIRM THE DEVICE INFORMATION AGAINST THE INFORMATION LISTED WITHIN GCH NOR CONFIRM THE DEVICE THAT WAS SENT BACK AS THE REPORTED COMPLAINT DEVICE, THE DEVICE INFORMATION FROM THE DISPLAY BOX IS LISTED AS: DEVICE NAME: PLASMABLADE 3.0S, LOT NUMBER: 0210643103, EXPIRATION DATE: 11-JAN-2019. THE EEPROM VERIFICATION WAS UTILIZED TO OBTAIN THE DEVICE INFORMATION, THE DEVICE INFORMATION FROM THE EEPROM VERIFICATION READER IS LISTED AS: DEVICE # 1: HANDPIECE TYPE: PLASMABLADE 3.0S, LOT NUMBER: 0210643118. THE DEVICE INFORMATION WAS CONFIRMED AGAINST THE INFORMATION LISTED WITHIN GCH FROM THE EEPROM VERIFICATION READER. DEVICE # 2: HANDPIECE TYPE: PLASMABLADE 3.0S, LOT NUMBER: 0210643103. THE DEVICE INFORMATION DOES NOT MATCH THE POPULATED PLI INFORMATION THAT IS LISTED WITHIN GCH, THEREFORE, IT IS NEITHER POSSIBLE TO CONFIRM THE DEVICE INFORMATION AGAINST THE INFORMATION LISTED WITHIN GCH NOR CONFIRM THE DEVICE THAT WAS SENT BACK AS THE REPORTED COMPLAINT DEVICE. THERE WAS NO PAPERWORK PROVIDED. DEVICE VISUAL INSPECTION: ¿ DEVICE # 1: THE DEVICE IS USED WITH EXCESSIVE AMOUNTS OF BLOOD ON HANDLE, NOSE, FINGER GRIP AND ELECTRODE. THERE IS BLOOD AND OTHER BIOLOGICAL FLUIDS PRESENT ALONG THE INNER SHAFT. THE SUCTION TUBING CONTAINS DRIED BLOOD. THE PLASTIC CLIPS THAT SECURE THE CORD TO THE SUCTION TUBING HAVE BEEN REMOVED. THE ELECTRODE INSULATION COATING IS DAMAGED, PEELING AND SCRATCHED WHICH VISUALLY RELATES TO THE REPORTED COMPLAINT DESCRIPTION, FIGURE # 1 THRU FIGURE # 3. THE HEAT SHRINK IS SCRATCHED WHICH IS CONSISTENT WITH THE IMPROPER USE AND CLEANING, SUCH AS WITH AN ABRASIVE MATERIAL, SCRATCH PAD, FIGURE # 1 THRU FIGURE # 3. THE SUCTION OPENING IS CLOGGED WITH EXCESSIVE TISSUE AND COAGULUM BUILDUP, WHICH CAN CAUSE DIMINISHED DEVICE PERFORMANCE, FIGURE # 4. DEVICE # 2: THE DEVICE IS USED WITH EXCESSIVE AMOUNTS OF BLOOD ON HANDLE, NOSE, FINGER GRIP AND ELECTRODE. THERE IS BLOOD AND OTHER BIOLOGICAL FLUIDS PRESENT ALONG THE INNER SHAFT. THE SUCTION TUBING CONTAINS DRIED BLOOD. THE PLASTIC CLIPS THAT SECURE THE CORD TO THE SUCTION TUBING HAVE BEEN REMOVED. THE ELECTRODE INSULATION COATING IS DAMAGED, PEELING AND SCRATCHED WHICH VISUALLY RELATES TO THE REPORTED COMPLAINT DESCRIPTION, FIGURE # 5 THRU FIGURE # 7. THE HEAT SHRINK IS SCRATCHED WHICH IS CONSISTENT WITH THE IMPROPER USE AND CLEANING, SUCH AS WITH AN ABRASIVE MATERIAL, SCRATCH PAD, FIGURE # 5 THRU FIGURE # 7. THE SUCTION OPENING IS CLOGGED WITH EXCESSIVE TISSUE AND COAGULUM BUILDUP, WHICH CAN CAUSE DIMINISHED DEVICE PERFORMANCE, FIGURE # 8. FUNCTIONAL INSPECTION: DEVICE # 1: BOTH CUT AND COAG BUTTONS HAVE A DEFINITIVE TACTILE FEEL. THE RETURNED PLASMABLADE 3.0S DEVICES WERE CONNECTED TO THE COMPLAINT LAB AEX GENERATOR AND THE EXPECTED E5 ERROR CODE, ¿END OF LIFE¿, WAS DISPLAYED CONFIRMING THE DEVICE HAD BEEN SUCCESSFULLY ACTIVATED PRIOR TO THIS COMPLAINT INVESTIGATION. THE DEVICE WAS ACTIVATED TWENTY-FIVE IN SUCCESSION ON BOTH CUT AND COAG MODES WITH NO FAILURES TO ACTIVATE THE DEVICE UPON DEPRESSION OF THE BUTTONS. THE DEVICE WAS TESTED FOR FUNCTIONALITY, ACTIVATION AND TEST FIRE - CUT AND COAG, VIA ACTIVATION IN GROUNDED SALINE, PRODUCING ACCEPTABLE RESULTS. A PLASMA FIELD WAS PRESENT AT THE ELECTRODE AND THE SOUND AND FUNCTION OF THE GENERATOR WERE REPRESENTATIVE OF NORMAL OPERATION. THE PULL FORCE TEST, PLUG EXTRACTION FORCE FROM THE GENERATOR, WAS PERFORMED TO DETERMINE IF THERE IS A LOOSE CONNECTION BETWEEN THE DEVICE AND THE GENERATOR. THE PLUG EXTRACTION FORCE FROM THE AEX GENERATOR WAS MEASURED FOR THE TENSION PEAK FORCE FOR THE 7-PIN RECEPTACLE; WHERE THE ACCEPTABLE TOLERANCE LIMITS OF (4.01 LBS. ± 1.96 LBS.) AND WITHIN THE RANGE OF (2.05 LBS. ¿ 5.97 LBS.) IS REQUIRED WHEN USING PLASMABLADE DEVICES (EXTRACTING AT A RATE OF LESS THAN ONE POUND OF FORCE PER SECOND). THE PLUG EXTRACTION FORCE MET THE PRODUCT SPECIFICATION REQUIREMENTS, PRODUCING ACCEPTABLE RESULTS, TABLE # 1. TABLE # 1: PLASMABLADE PLUG EXTRACTION FORCE - AEX GENERATOR EXTRACTION CYCLES MEASURED TENSION PEAK FORCE (LBS.) PRODUCT SPECIFICATION 31-10-1365 REV. N ACCEPTABLE RANGE (2.05 LBS. ¿ 5.97 LBS.) RESULTS (2.05 LBS. ¿ 5.97 LBS.) 1ST 2.11 LBS. P ASS 2ND 2.30 LBS. P ASS 3RD 2.20 LBS. P ASS AVERAGE 2.20 LBS. PASS DEVICE # 2: BOTH CUT AND COAG BUTTONS HAVE A DEFINITIVE TACTILE FEEL. THE RETURNED PLASMABLADE 3.0S DEVICE WAS CONNECTED TO THE COMPLAINT LAB AEX GENERATOR AND THE EXPECTED E5 ERROR CODE, ¿END OF LIFE¿, WAS DISPLAYED CONFIRMING THE DEVICE HAD BEEN SUCCESSFULLY ACTIVATED PRIOR TO THIS COMPLAINT INVESTIGATION. THE DEVICE WAS ACTIVATED TWENTY-FIVE IN SUCCESSION ON BOTH CUT AND COAG MODES WITH NO FAILURES TO ACTIVATE THE DEVICE UPON DEPRESSION OF THE BUTTONS. THE DEVICE WAS TESTED FOR FUNCTIONALITY, ACTIVATION AND TEST FIRE - CUT AND COAG, VIA ACTIVATION IN GROUNDED SALINE, PRODUCING ACCEPTABLE RESULTS. A PLASMA FIELD WAS PRESENT AT THE ELECTRODE AND THE SOUND AND FUNCTION OF THE GENERATOR WERE REPRESENTATIVE OF NORMAL OPERATION. THE PULL FORCE TEST, PLUG EXTRACTION FORCE FROM THE GENERATOR, WAS PERFORMED TO DETERMINE IF THERE IS A LOOSE CONNECTION BETWEEN THE DEVICE AND THE GENERATOR. THE PLUG EXTRACTION FORCE FROM THE AEX GENERATOR WAS MEASURED FOR THE TENSION PEAK FORCE FOR THE 7-PIN RECEPTACLE; WHERE THE ACCEPTABLE TOLERANCE LIMITS OF (4.01 LBS. ± 1.96 LBS.) AND WITHIN THE RANGE OF (2.05 LBS. ¿ 5.97 LBS.) IS REQUIRED WHEN USING PLASMABLADE DEVICES (EXTRACTING AT A RATE OF LESS THAN ONE POUND OF FORCE PER SECOND). THE PLUG EXTRACTION FORCE MET THE PRODUCT SPECIFICATION REQUIREMENTS, PRODUCING ACCEPTABLE RESULTS, TABLE # 2. TABLE # 2: PLASMABLADE PLUG EXTRACTION FORCE - AEX GENERATOR EXTRACTION CYCLES MEASURED TENSION PEAK FORCE (LBS.) PRODUCT SPECIFICATION 31-10-1365 REV. N ACCEPTABLE RANGE (2.05 LBS. ¿ 5.97 LBS .) RESULTS (2.05 LBS. ¿ 5.97 LBS.) 1ST 3.13 LBS. P ASS 2ND 2.32 LBS. PASS 3RD 2.64 LBS. PASS AVERAGE 2.70 LBS. PASS LHR REVIEW: A REVIEW OF THE LHR FOR LOT # 0210643118 REVEALED THERE WERE NO PROBLEMS DURING MANUFACTURING THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT DESCRIPTION. INVESTIGATION CONCLUSION: COMPLAINT CONFIRMED: THE REPORTED ISSUE CONTAINED WITHIN GCH WAS VISUALLY CONFIRMED WITHIN THE LABORATORY ENVIRONMENT. INSUFFICIENT CLEANING AND USE OF THE ELECTRODE CAN CAUSE TISSUE, COAGULUM AND ESCHAR BUILDUP ON AND AROUND THE ELECTRODE AND HEAT SHRINK. WHEN THIS OCCURS, THE RF ENERGY PATH MAY BE ALTERED SUCH THAT THE ENERGY IS DIRECTED TO THE TISSUE ON THE ELECTRODE, RATHER THAN TO THE PATIENT; IT IS PROBABLE THE HEAT SHRINK WILL DEGRADE, THE ELECTRODE INSULATION COATING CAN BE COMPROMISED, AND CAN CAUSE DIMINISHED DEVICE PERFORMANCE. THIS COMPLAINT WILL BE TRACKED AND TRENDED IN GCH. REFERENCE DOCUMENTS: 42-10-1020 REV. H - WORK INSTRUCTIONS FOR COMPLAINT INVESTIGATIONS - DISPOSABLE DEVICES 31-10-1369 REV. K - PRODUCT SPECIFICATION AND QUALITY PLAN - PLASMABLADE 3.0 70-10-1452 REV. B - PEAK PLASMABLADE 3.0S - LOCKING MECHANISM ¿ IFU 31-10-1365 REV. N - AEX - PRODUCT SPECIFICATION AND QUALITY PLAN 70-10-1455 REV. F - AEX GENERATOR - OPERATOR¿S MANUAL 61-10-0017 REV. H - DEVICE BUTTON TACTILE TEST PROCEDURE TEST EQUIPMENT: EQP # EQP - NAME - MANUFACTURER 7321 FORCE GAUGE ¿ FORCE TEN ¿ WAGNER INSTRUMENTS 7225 AEX GENERATOR 7058 EEPROM BYPASS CONNECTOR 7213 EEPROM VERIFICATION READER. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
(B)(4). PATIENT INFORMATION INCOMPLETE AND MISSING PATIENT INFORMATION UNABLE TO BE OBTAINED DESPITE A GOOD FAITH EFFORT MADE TO OBTAIN THE INFORMATION FROM THE CUSTOMER. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ABOUT 2 HOURS INTO THE CASE, THE SURGEON REPORTED THE BLACK COATING ON THE PLAMSABLADE DEVICE TIP PEELED COMPLETELY OFF. A SECOND PLASMABLADE WAS USED AND WITHIN 5 MINUTES THE SURGEON REPORTED PEELING AT THE DEVICE TIP. NOTHING FELL INTO THE PATIENT AND THERE WAS NO PATIENT IMPACT.
ABOUT 2 HOURS INTO THE CASE, THE SURGEON REPORTED THE BLACK COATING ON THE PLAMSABLADE DEVICE TIP PEELED COMPLETELY OFF. A SECOND PLASMABLADE WAS USED AND WITHIN 5 MINUTES THE SURGEON REPORTED PEELING AT THE DEVICE TIP. NOTHING FELL INTO THE PATIENT AND THERE WAS NO PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 642300 | PLASMABLADE 3.0S | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | MEDTRONIC ADVANCED ENERGY, LLC | PS210-030S | 0210643118 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |