FENESTRATED DISSCT 10MM JAW 5MM 36CM ESU
Report
- Report Number
- 1923569-2023-00009
- Event Type
- Malfunction
- Date Received
- June 22, 2023
- Date of Event
- May 31, 2023
- Report Date
- July 6, 2023
- Manufacturer
- CAREFUSION - ST. LOUIS
- Product Code
- GEI
- UDI-DI
- 10885403159183
- PMA / PMN Number
- K930666
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
8080855 FOLLOW UP MDR: UPON RECEIPT THE COMPLAINT SAMPLE RECEIVED A VISUAL EXAMINATION AND A FUNCTIONAL CHECK. THE FOLLOWING MARKINGS WERE FOUND ON THE DEVICE: SP90-6335, L22, A 2D UDI, AND SNOWDEN PENCER. NO EVIDENCE WAS FOUND THAT THE DEVICE IS NOT AUTHENTIC. UPON VISUAL EXAMINATION AND FUNCTIONAL CHECK, THE COMPLAINT FAILURE MODE WAS NOT CONFIRMED, HOWEVER, THE RESULTS HERE ARE A BIT INCONCLUSIVE. NO VISUAL OUTER INDICATION WAS OBSERVED THAT THE DEVICE HAD BEEN THE RESULT OF ANY ELECTRIC ARCING, THERE WERE NO BURN MARKS VISIBLE AROUND THE BOVIE POST, ON THE INSULATION OF THE SHAVE, THE HANDLE, OR ON ANY OF THE ASSOCIATED COMPONENTS. THE DEVICE WAS THEN HY-POT TESTED PER 02-0044, AND DID NOT SPARK OR SMOKE. TO CLARIFY, THE HY-POT TEST WAS PERFORMED AT 3 KVP, 3 TIMES GREATER THAN THE 1 KVP THIS DEVICE IS RATED FOR BY THE INSTRUCTIONS FOR USE CF36-1831. THE DEVICE PASSED HYPOT TESTING, NO SMOKING OR SPARKS WERE IDENTIFIED. THE ELECTRICALLY CONDUCTIVE PATH OF THE DEVICE IS RELATIVELY SIMPLE, FROM DISTAL END TO PROXIMAL END, THE FOLLOWING COMPONENTS ARE CONDUCTIVE AND KEPT IN CONSTANT CONTACT WITH EACH OTHER; JAWS, CLEVIS, SHAFT, DETENT BALL AND SET SCREW, BEARING CLIP/BEARING, BOVIE POST. IT IS NOT POSSIBLE FOR THERE TO BE INTERMITTENT CONTACT HERE, WHILE THE DETENT FUNCTION IS STILL FUNCTIONAL, AND IT WAS FOUND TO BE FUNCTIONAL. WERE IT NOT FUNCTIONAL, THE POSSIBILITY OF A DISCONNECTED ALIGNMENT WOULD STILL BE REMOTE. THIS WOULD INDICATE ONE OF 3 POSSIBLE SCENARIOS IS MOST LIKELY RESPONSIBLE FOR THE CUSTOMERS OBSERVATION 1) A VOLTAGE SETTING WELL ABOVE 3KVP WAS USED, AND THE AMOUNT OF ELECTRICAL ENERGY TRAVERSING THE INTENDED PATH FAR EXCEEDED ITS DESIGN LIMITATIONS, AND SAID ELECTRICAL ENERGY WAS CONVERTED INTO THERMAL ENERGY 2) THE DEVICE WAS NOT ADEQUATELY CLEANED FROM A PRIOR CLEANING AND STERILIZATION CYCLE, THE ELECTRIC PATH CREATED BY THIS MOISTURE INCLUDED WATER (OR OTHER SOLUTION), AND TOO MUCH ENERGY WAS TRANSMITTED ALONG THIS NEW PATH, CONVERTING TO THERMAL ENERGY, COOKING OFF THE WATER, AND CAUSING A DISAPPEARING PATH TO SPARK AND SMOKE OR 3) THE BOVIE CORD WAS ENERGIZED WHEN IT WAS CONNECTED TO THE DEVICE, THE DEVICE WAS GROUNDED COMPLETING THE CIRCUIT, AND THE BOVIE CORD AND HANDLE SPARKED FOR THE SAME REASONS YOUR VEHICLES BATTERY TERMINALS SPARK WHEN YOU FIRST CONNECT THEM, TOO MUCH ELECTRICITY TRAVERSING TOO SMALL A CONDUCTIVE CROSS SECTION. THE DEVICE WAS COMPLETELY DISASSEMBLED, AND A SMALL PIECE OF FOREIGN MATTER WAS FOUND BETWEEN THE GROOVE ON THE SHAFT, AND THE SET SCREW FOR THE BEARING. WHERE THE DETENT BALL WOULD PROVIDE A CONSTANT CONDUCTIVE PATH, THE SET SCREW IS CAPABLE OF ONLY BEING IN CONTACT INTERMITTENTLY, SO THIS JOINT IS NOT THE PRIMARY MEANS OF CONDUCTING ELECTRICITY. THE FOREIGN MATTER WAS NOT UV LUMINESCENT, SO IT IS NOT THE THREAD LOCKING ADHESIVE USED AT THE SET SCREW/BEARING JOINT. NEITHER IS IT A SHADOW OF YELLOW/ORANGE TO INDICATE IT IS PART OF THE THERMAL TAPE USED IN THE ASSEMBLY OF THE BEARING. IT IS NOT INDICATIVE OF ANY MATERIALS USED IN THE MANUFACTURING OF THIS DEVICE. IT DOES APPEAR TO BE SCORCHED AND MAY EXPLAIN THE OBSERVATION OF SMOKE. THIS MATERIAL APPEARS TO BE A PLASTIC (POLYMER IN NATURE). THE MATERIAL WAS TESTED WITH A CALIBRATED MULTIMETER AND WAS CONFIRMED TO NOT BE ELECTRICALLY CONDUCTIVE, INDICATING THAT THE FOREIGN MATTER WAS NOT THE CAUSE OF THE FAILURE MODE, JUST A CONSEQUENCE OF WHATEVER UNDERLYING OVERLOAD EVENT CAUSED SPARKS. IT SHOULD ALSO BE NOTED THAT THE COMPLAINT COMMUNICATION INDICATED THAT THE DEVICE ¿SPARKED WHEN CONNECTED¿ TO THE BOVIE CORD. IF THIS INDICATES THAT THE ACT OF CONNECTING AN ENERGIZED CORD MADE THE DEVICE SPARK, THEN SCENARIO 3 WOULD SEEM TO BE THE CAUSE OF THE COMPLAINT FAILURE MODE. CUSTOMER IS ADVISED THE FOLLOWING INSTRUCTIONS ARE IN THE IFU, CF36-1831: A) ¿CONNECT ADAPTORS AND ACCESSORIES TO THE ELECTROSURGICAL UNIT ONLY WHEN THE UNIT IS OFF. FAILURE TO DO SO MAY RESULT IN AN INJURY OR ELECTRICAL SHOCK TO THE PATIENT OR OPERATING ROOM PERSONNEL.¿ B) ¿CONDUCTIVE FLUIDS IN DIRECT CONTACT WITH AN ACTIVE ELECTRODE MAY CARRY ELECTRICAL CURRENT OR HEAT, WHICH MAY CAUSE UNINTENDED BURNS TO THE PATIENT¿ AND C) ¿DO NOT ACTIVATE THE ELECTROSURGICAL UNIT UNTIL THE DEVICE HAS MADE CONTACT WITH THE PATIENT¿. THE DEVICE SHOULD ONLY BE ENERGIZED WHEN IT IS IN DIRECT USE, AND AT THE LOWEST POWER SETTING NECESSARY FOR THE TASK. A REVIEW OF THE COMPLAINT HISTORY LOG WAS PERFORMED, NO OTHER COMPLAINTS FROM OTHER CUSTOMERS FOR SP90-6335 WITH A DATE CODE OF L22 WERE IDENTIFIED TO INDICATE A PROBLEM WITH THE PRODUCTION BATCH. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS ALSO PERFORMED, NO NON-CONFORMANCES WERE IDENTIFIED WHICH COULD HAVE CONTRIBUTED TO THE COMPLAINT FAILURE MODE. BASED ON 1) THE STATEMENT THAT THE DEVICE SPARKED ¿WHEN CONNECTED¿ 2) THE PASSING RESULT OF THE DEVICE WHEN HY-POT TESTED PER 02-0044 AT 3 TIMES GREATER POWER SETTING THAN THAT ALLOWED BY THE INSTRUCTIONS FOR USE FOR THIS DEVICE 3) THE ABSENCE OF ANY OUTWARD BURN MARKS OR INDICATIONS OF AN ELECTRICAL ISSUE AND FULL FUNCTIONALITY OF THE DETENT FEATURE, 4) THE ABSENCE OF CONDUCTIVITY FOR THE FOREIGN MATTER 5) THE ABSENCE OF A COMPLAINT FROM ANOTHER CUSTOMER TO INDICATE AN ISSUE WITH THE PRODUCTION BATCH FOR THIS DEVICE AND 6) THE ABSENCE OF A NON-CONFORMANCE IN THE MANUFACTURING RECORD (DHR) FOR THIS DEVICE; THE MOST PROBABLE ROOT CAUSE OF THE COMPLAINT FAILURE MODE IS USE ERROR IN THE SUDDEN CONNECTION OF AN ENERGIZE BOVIE CORD TO A GROUNDED DEVICE.
(B)(4)01JUN2023 WRITER SENT THE CUSTOMER AN EMAIL ACKNOWLEDGING RECEIPT OF THE COMPLAINT AND REQUESTED FOLLOW UP INFORMATION INCLUDING AS TO IF THERE WAS ANY PATIENT IMPACT RELATED TO THIS EVENT. WRITER PROVIDED CONTACT INFORMATION. DEVICE NOT YET EVALUATED, IF THE DEVICE IS EVALUATED A FOLLOW UP WILL BE SENT. H3 OTHER TEXT : SEE H10.
MATERIAL#: SP90-6335. BATCH#: 90-6335 L22. IT WAS REPORTED BY THE CUSTOMER THAT "DUCKBILL LAP DISSECTOR SPARKED WHEN CONNECTED TO MONOPOLAR CORD. SPARKED AND SMOKED AT CONNECTION SITE ON HANDLE, NOT AT DISTAL END OF INSTRUMENT. OXYGEN LEVELS NORMAL IN THE ROOM. INSTRUMENT OUTSIDE PATIENT AT THE TIME - NO PATIENT IMPACT DURING EVENT. NOT NEAR ANY CLIPS OR STAPLE LINE, HOWEVER DOCTOR DOES USE METAL TROCARS. INSTRUMENT SET ASIDE TO BE SENT OUT FOR FOLLOW UP INSPECTION". VERBATIM: DUCKBILL LAP DISSECTOR SPARKED WHEN CONNECTED TO MONOPOLAR CORD. SPARKED AND SMOKED AT CONNECTION SITE ON HANDLE, NOT AT DISTAL END OF INSTRUMENT. OXYGEN LEVELS NORMAL IN THE ROOM. INSTRUMENT OUTSIDE PATIENT AT THE TIME - NO PATIENT IMPACT DURING EVENT. NOT NEAR ANY CLIPS OR STAPLE LINE, HOWEVER DOCTOR DOES USE METAL TROCARS. INSTRUMENT SET ASIDE TO BE SENT OUT FOR FOLLOW UP INSPECTION. ADDITIONAL INFO RECEIVED ON 2 JUNE 2023. ¿ WHAT IS THE LOT NUMBER? 90-6335 L22. ¿ CAN YOU DESCRIBE WHAT WAS OBSERVED? WHEN THE SURGEON WENT TO FIRE THE INSTRUMENT A JARIT MONOPOLAR CORD WAS ATTACHED TO THE V.MUELLER INSTRUMENT WHICH WAS INSIDE THE TROCAR, A SPARK FIRED WITH SMOKE AND THE MONOPOLAR JARIT CORD BURNED IN HALF. ¿ WAS THE PRODUCT RECEIVED IN THIS CONDITION? NO. ¿ IF NOT, WHAT WAS THE PRODUCT BEING USED FOR WHEN THE REPORTED ISSUE WAS OBSERVED? IT WAS BEING USED TO DISSECT FOR A LAPAROSCOPIC GALLBLADDER PROCEDURE. ¿ DO YOU HAVE PHOTOS SHOWING THE REPORTED ISSUE? I ONLY HAVE PHOTOS OF THE JARIT MONOPOLAR CORD THE V. MUELLER INSTRUMENT HAS NO APPARENT/ VISIBLE DAMAGE. ¿ IS THE PRODUCT AVAILABLE TO SEND BACK TO US FOR AN EVALUATION? IF SO, PLEASE PROVIDE YOUR ADDRESS AND A PREPAID FEDEX LABEL WILL BE PROVIDED. YES, (B)(6). ¿ WHAT IS THE FULL NAME AND ADDRESS OF THE FACILITY FOR WHERE THE ISSUE OCCURRED? (B)(6) HOSPITAL.
MATERIAL#: SP90-6335 BATCH#: 90-6335 L22 IT WAS REPORTED BY THE CUSTOMER THAT "DUCKBILL LAP DISSECTOR SPARKED WHEN CONNECTED TO MONOPOLAR CORD. SPARKED AND SMOKED AT CONNECTION SITE ON HANDLE, NOT AT DISTAL END OF INSTRUMENT. OXYGEN LEVELS NORMAL IN THE ROOM. INSTRUMENT OUTSIDE PATIENT AT THE TIME - NO PATIENT IMPACT DURING EVENT. NOT NEAR ANY CLIPS OR STAPLE LINE, HOWEVER DOCTOR DOES USE METAL TROCARS. INSTRUMENT SET ASIDE TO BE SENT OUT FOR FOLLOW UP INSPECTION". VERBATIM: DUCKBILL LAP DISSECTOR SPARKED WHEN CONNECTED TO MONOPOLAR CORD. SPARKED AND SMOKED AT CONNECTION SITE ON HANDLE, NOT AT DISTAL END OF INSTRUMENT. OXYGEN LEVELS NORMAL IN THE ROOM. INSTRUMENT OUTSIDE PATIENT AT THE TIME - NO PATIENT IMPACT DURING EVENT. NOT NEAR ANY CLIPS OR STAPLE LINE, HOWEVER DOCTOR DOES USE METAL TROCARS. INSTRUMENT SET ASIDE TO BE SENT OUT FOR FOLLOW UP INSPECTION. ADDITIONAL INFO RECEIVED ON 2 JUNE 2023 WHAT IS THE LOT NUMBER? 90-6335 L22 CAN YOU DESCRIBE WHAT WAS OBSERVED? WHEN THE SURGEON WENT TO FIRE THE INSTRUMENT A JARIT MONOPOLAR CORD WAS ATTACHED TO THE V.MUELLER INSTRUMENT WHICH WAS INSIDE THE TROCAR, A SPARK FIRED WITH SMOKE AND THE MONOPOLAR JARIT CORD BURNED IN HALF. WAS THE PRODUCT RECEIVED IN THIS CONDITION? NO IF NOT, WHAT WAS THE PRODUCT BEING USED FOR WHEN THE REPORTED ISSUE WAS OBSERVED? IT WAS BEING USED TO DISSECT FOR A LAPAROSCOPIC GALLBLADDER PROCEDURE DO YOU HAVE PHOTOS SHOWING THE REPORTED ISSUE? I ONLY HAVE PHOTOS OF THE JARIT MONOPOLAR CORD THE V. MUELLER INSTRUMENT HAS NO APPARENT/ VISIBLE DAMAGE IS THE PRODUCT AVAILABLE TO SEND BACK TO US FOR AN EVALUATION? IF SO, PLEASE PROVIDE YOUR ADDRESS AND A PREPAID FEDEX LABEL WILL BE PROVIDED. YES, (B)(6) WHAT IS THE FULL NAME AND ADDRESS OF THE FACILITY FOR WHERE THE ISSUE OCCURRED? (B)(6)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 71579 | FENESTRATED DISSCT 10MM JAW 5MM 36CM ESU | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | CAREFUSION - ST. LOUIS | SP90-6335 | L22 | 10885403159183 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |