PLASMABLADE 4.0
Report
- Report Number
- 1226420-2014-00046
- Event Type
- Malfunction
- Date Received
- July 15, 2014
- Date of Event
- June 16, 2014
- Report Date
- June 16, 2014
- Manufacturer
- MEDTRONIC ADVANCED ENERGY, LLC
- Product Code
- DWG
- PMA / PMN Number
- K073057
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
(B)(4). INVESTIGATION PLAN: VISUAL INSPECTION FUNCTIONAL INSPECTION (IF APPLICABLE) LHR REVIEW TESTING PERFORMED: (FOR THE YES/NO QUESTIONS PLEASE DELETE THE ANSWER THAT IS NOT APPLICABLE, LEAVING THE ANSWER THAT PERTAINS TO THE QUESTIONS ASKED) COMPLAINT DEVICE DETAILS: (MUST BE FILLED OUT PER DEVICE RETURNED) OBTAIN INFORMATION FROM THE RETURNED DEVICE DEVICE: PLASMABLADE¿ 4.0 ¿ DEMO ¿ ¿NOT FOR HUMAN USE¿ PRODUCT CODE (SKU): UNKNOWN SERIAL / LOT NUMBER: UNKNOWN EXPIRATION DATE: UNKNOWN QUANTITY RETURNED: 1 ANY DISCREPANCIES IDENTIFIED BETWEEN DEVICE INFO OBTAINED FROM RETURNED PRODUCT AND DEVICE INFO POPULATED IN PRODUCT LINE ITEMS SECTION IN GCH: YES IF YES, DESCRIBE: THE DEVICE INFORMATION WAS OBTAINED FROM GCH AND IS LISTED BELOW SINCE THERE WAS NO ORIGINAL PACKAGING RETURNED, THEREFORE, IT IS NOT POSSIBLE TO CONFIRM THE DEVICE THAT WAS SENT BACK AS THE REPORTED COMPLAINT DEVICE . PRODUCT CODE (SKU): PS200-040DEMO SERIAL / LOT NUMBER: (B)(4) EXPIRATION DATE: NOT APPLICABLE ¿ DEMO VISUAL INSPECTION (PACKAGING): SHIPPING CONTAINER: YES PACKAGING TO FILL NEGATIVE SPACE: NO IF YES, DESCRIBE: DEVICE SAFETY PACKAGING: NO ADDITIONAL PAPERWORK INCLUDED: NO VISUAL INSPECTION (PRODUCT): (MUST BE FILLED OUT FOR EACH DEVICE RETURNED) EVIDENCE OF USE: YES IF YES, DESCRIBE: A DEMO DEVICE DOES NOT CONTAIN A 24-HOUR TIME-OUT CHIP TO PREVENT RE-USE OF THE DEVICE AND THEREFORE THIS IS NOT A SINGLE USE DEVICE. THE ELECTRODE TIP IS DETACHED AND MISSING FROM THE DEVICE, FIGURE # 3 AND FIGURE # 4. THE DETACHED ELECTRODE TIP WAS NOT RETURNED WITH THE DEVICE DEMO DEVICE LABELLED WITH STICKER AS ¿NOT FOR HUMAN USE¿ EVIDENCE OF DAMAGE: YES IF YES, DESCRIBE: THE ELECTRODE TIP IS DETACHED AND MISSING FROM THE DEVICE, FIGURE # 1 AND FIGURE # 2. THE DETACHED ELECTRODE TIP WAS NOT RETURNED WITH THE DEVICE BUTTON TACTILE FEEL: YES IF NO, DESCRIBE: VISUAL SIGNS RELATED COMPLAINT DESCRIPTION: YES IF YES, DESCRIBE: THE ELECTRODE TIP IS DETACHED AND MISSING FROM THE DEVICE FUNCTIONAL INSPECTION: (IF INSPECTION PERFORMED, MUST BE FILLED OUT FOR EACH DEVICE TESTED) FUNCTIONAL INSPECTION IS NOT POSSIBLE SINCE THE ELECTRODE TIP IS DETACHED AND MISSING FROM THE DEVICE. LHR REVIEW: [LOT# (OF RETURNED PRODUCT OR WHAT IS POPULATED AS THE LOT# IN GCH), ANY DEVIATIONS, FAILURES, SCRAP, ETC. PERTAINING TO COMPLAINT DESCRIPTION] A REVIEW OF THE LHR FOR THE PLASMABLADE¿ 4.0 WITH LOT # 52327 REVEALED THAT THERE WERE NO PROBLEMS DURING MANUFACTURING THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. INVESTIGATION CONCLUSION: (COMPLAINT CONFIRMED/NOT CONFIRMED, SUMMARY OF FINDINGS, LIKELY CAUSE OF FAILURE, POTENTIAL CAUSE OF REPORTED COMPLAINT, RECOMMENDATIONS) THE COMPLAINT IS CONFIRMED AND FOUND TO BE OUT OF PRODUCT SPECIFICATION FOR THE ¿PLASMABLADE¿ 4.0 DEMO ¿ TIP DETACHED¿ ISSUE THAT WAS REPORTED IN THE COMPLAINT DESCRIPTION. THE DEVICE WAS MANUFACTURED AT (B)(4). THE DEVICE WAS ASSEMBLED ACCORDING TO DOCUMENT NUMBER SA-00004 REV. H ¿ FIGURE # 5 ¿ TIP/SHAFT SUB-ASSEMBLY, PLASMABLADE¿ 4.0 ¿ SUB-ASSEMBLY SPECIFICATION DOCUMENT WHICH USES TWO SEPARATE PIECES FOR THE BLADE TIP REQUIRING A SPOT WELD CENTERED ON THE BENDABLE SHAFT OVER THE BLADE. THE BLADE TIP BROKE JUST ABOVE THE SPOT WELD ON THE BENDABLE SHAFT AND BELOW THE COATING OF THE BLADE TIP. THE DEVICE IS A DEMO DEVICE WHICH MEANS THAT THE DEVICE WAS USED MANY TIMES AND THE SHAFT BENT MANY TIMES AND IT CANNOT BE DETERMINED HOW MANY TIMES THE DEVICE WAS ACTUALLY USED FOR DEMONSTRATION. SINCE IT CANNOT BE DETERMINED HOW MANY TIMES THE SHAFT WAS BENT IT IS LIKELY THAT THE SHAFT WAS BENT MORE THAN THREE TIMES, IFU RECOMMENDS BENDING THE SHAFT NO MORE THAN THREE TIMES AND NOT TO EXCEED A 45 DEGREES ANGLE, NOR CAN IT BE DETERMINE WHERE THE SHAFT WAS BENT, AT THE SHAFT OR THE BLADE TIP MAY HAVE CAUSED THE SHAFT TO WEAKEN OVER TIME AND CONTRIBUTED TO THE BLADE TIP AND SHAFT FAILURE. THE HEAT SHRINK WAS CUT BACK TO EXPOSE THE SHAFT, RUST WAS OBSERVED TO BE PRESENT ON THE SHAFT WITH THE SHAFT DEGRADING AS EVIDENCED BY THE RUST AN UNEVEN BREAK AND COMPROMISED SHAFT. THE INTEGRITY OF THE SHAFT WAS COMPROMISED MORE THAN LIKELY DUE TO MUFTI-USE ACTIVITY AND IT IS POSSIBLE THAT THE DEVICE NEVER FULLY DRIED OUT AND REMAINED WET AND THUS THE INTEGRITY OF THE MATERIAL DETERIORATED. IT IS ALSO POSSIBLE THAT THE DEVICE BLADE DETERIORATION WAS CAUSED BE THE DEVICE BEING SUBMERGED IN SALINE MANY TIMES DURING DEVICE DEMONSTRATION AND THE SALINE SALT BEING A CORROSIVE SUBSTANCE CONTINUED TO WEAKEN THE SHAFT. THIS IS UNLIKELY NO HAPPEN WITHIN A HOSPITAL ENVIRONMENT SINCE PLASMABLADE¿ 4.0 DEVICES ARE INTENDED TO BE USED AS A SINGLE USE DEVICE AND THE BLADE TIP IS NOW MANUFACTURED AS A SINGLE PIECE COATED BLADE TIP PER SA-00087 REV.A ¿ FIGURE # 6 ¿ BLADE, GROUND, 4.0, GLASS COATED. THE COMPLAINT WILL BE TRACKED AND TRENDED IN GCH. IFU 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 USER INJURY. USE FINGER FORCE TO SHAPE THE SHAFT; DO NOT USE FORCEPS AS THIS COULD DAMAGE THE DEVICE. BEFORE DEMONSTRATION: SHAPING THE SHAFT: IF NEEDED, CAREFULLY USE FINGER FORCE TO SHAPE THE SHAFT. THE SHAFT MAY BE BENT TO A MAXIMUM ANGLE OF 45° FROM THE PLANE OF THE SHAFT. DO NOT BEND MORE THAN THREE TIMES. EXCESSIVE BENDING OF THE SHAFT MAY COMPROMISE PERFORMANCE OF THE DEVICE OR CAUSE DEVICE FAILURE, WHICH COULD RESULT IN USER INJURY. NOTE: DO NOT BEND THE ELECTRODE TIP AS THIS MAY DAMAGE THE TIP. REFERENCED DOCUMENTS: (LIST DOCUMENT NUMBER, TITLE, AND REVISION FOR ALL DOCUMENTS UTILIZED TO PERFORM COMPLAINT INVESTIGATION) 42-10-1020 REV. B ¿ WORK INSTRUCTIONS FOR COMPLAINT INVESTIGATIONS ¿ DISPOSABLE DEVICES 31-10-1368 REV. C ¿ PRODUCT SPECIFICATION AND QUALITY PLAN ¿ PLASMABLADE¿ 4.0 31-10-1368 REV. C ¿ QC TEST STANDARD ¿ PLASMABLADE 4.0 LBL-00116 REV. B ¿ PLASMABLADE¿ 4.0 ¿ IFU ¿ INSTRUCTIONS FOR USE LBL-00133 REV. B ¿ PLASMABLADE¿ 4.0 ¿ DEMO DEVICE ¿ IFU ¿ INSTRUCTIONS FOR USE 61-10-0017 REV. H ¿ DEVICE BUTTON TACTILE TEST PROCEDURE SA-00004 REV. H ¿ TIP/SHAFT SUB-ASSEMBLY SPECIFICATION ¿ PLASMABLADE¿ 4.0 SA-00087 REV. A ¿ BLADE ¿ GROUND - 4.0 - GLASS COATED TEST EQUIPMENT UTILIZED: (PLEASE DELETE THE EQUIPMENT NOT UTILIZED DURING THE COMPLAINT INVESTIGATION, LEAVING A LISTING OF THE EQUIPMENT UTILIZED TO PERFORM THE INVESTIGATION) EQP # EQP - NAME - MANUFACTURER N/A NO EQUIPMENT UTILIZED. (B)(4).
WHEN PERFORMING A CHICKEN DEMONSTRATION THE TIP OF THE DEVICE DETACHED FROM THE DEVICE SHAFT. NO SURGERY WAS INVOLVED AND A DIFFERENT DEVICE WAS USED TO COMPLETE THE DEMONSTRATION. THE DEVICE INVOLVED WAS A DEMONSTRATION HANDPIECE (NON-SINGLE USE).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 412255 | PLASMABLADE 4.0 | ELECTROSURGICAL DEVICE | DWG | MEDTRONIC ADVANCED ENERGY, LLC | PS200-040DEMO | 52327 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |