Description of Event or Problem · 1
PT HAD TONSILLECTOMY AND ADENOIDECTOMY WITH BILATERAL MYRINGOTOMY TUBE PLACEMENT/EXTRACTION AT 8:07. THE SURGEON REPORTED DIFFICULTY IN "GETTING GOOD BURN" DURING THE MONOPOLAR ACTIVE ELECTRODE USE. THE CIRCULATING RN REPORTS REPOSITIONING THE ACTIVE ELECTRODE ADAPTER AND THE SINGLE FOIL PAD ADAPTER, BOTH AT ENTRY POINT INTO THE ELECTROSURGICAL UNIT (ASPEN EXCALIBUR ESU). NOTE: ALARMS NEVER ACTIVATED DURING THE PROCEDURE. THE PT WAS PLACED ON A MEGADYNE GROUNDING PAD (CAPACATIVE COUPLED). DISCHARGED FROM SURGERY ROOM AT 8:37. THE FAMILY MEMBER DISCOVERED TWO WHITE LESIONS, QUARTER-SIZE, ON BILATERAL BUTTOCKS AT 9:15. THE FAMILY AND PT WENT IMMEDIATELY TO PLASTIC SURGEON FOR EVALUATION AND ONGOING TREATMENT WITH SILVADENE CREAM AT 11:10 AM. FINDINGS: THAT DAY, 7, 9, 10/02 AND 11 DAYS LATER, ASSESS/OBSERVED THAT VARIABLES CONTRIBUTING TO THE EVENT ARE AS FOLLOWS: 1. BASED ON CURRENT FACTS, MULTIPLE VARIABLES CONTRIBUTED TO THIS ADVERSE EVENT. THIS IS THE FIRST AND ONLY REPORTED ADVERSE EVENT RESULTING IN ADVERSE PT OUTCOME (SKIN LESIONS, POST-OP). THE ESU SYSTEM: 1. ASPEN EXCALIBUR ELECTROSURGERY UNIT ACQUIRED IN 04/1992, LIFE EXPECTANCY = 10 YRS. 2. MEGA 2000 DISPERSIVE ELECTRODE PAD ACQUIRED IN 5/2001, SINGLE FOIL MODE-CAPACATIVE. 3. >12 MOS PERIOD SINCE O.R. INSERVICE ON MEGA 2000 PAD. NOTE: INSERVICE BY MEGADYNE DISTRIBUTOR, STAFF DOES NOT RECALL ANY PRECAUTIONS INDICATED/DOCUMENTED REGARDING PEDIATRIC AND ALARM MONITORING LIMITATIONS. SALES LITERATURE ONLY DOCUMENT PROVIDED. 4. OR STAFF PERCEPTION OF ENHANCED PT SAFETY OF ALARM ACTIVATION BY ESU. A.) ESU ALARM ONLY ACTIVATES WITH IMPAIRED INTEGRITY OF CABLE CONNECTIONS (SINGLE AND DUAL FOIL MODES). B.) ESU ALARM DOES NOT ACTIVATE WITH CHANGE IN IMPEDENCE/CAPACITANCE OF A DISPERSIVE ELECTRODE PAD AS IT RELATES TO DIRECT CONTACT WITH THE PT, UNLESS IT IS DUAL FOIL PAD. 1,2,3. C. INSERVICE WITH CEUS 4/1999 FOR STAFF ONLY. OR STAFF NOT FULLY AWARE OF IMPORTANCE OF DUAL FOIL PAD (RETURN ELECTRODE MONITORING-RECQM) IN PT SAFETY. NOTE: OR STAFF USED DUAL FOIL ELECTRODE PADS PRIOR TO 5/01. CONTINUOUS RETURN ELECTRODE MONITORING WILL LIKELY BE A STANDARD OF CARE (AORN ET AL, IN THE NEAR FUTURE). 5. OR STAFF PERCEPTION OF ENHANCED PT SAFETY OF LARGE PAD (24 IN X 36 IN) COVERS APPROX 50% OR TABLE. BYPASS PROCESS OF FREQUENT CHECKS FOR CONTACT INTEGRITY BETWEEN THE PT AND THE PAD. NOTE: THE MEGA 2000 PAD IS COVERED WITH A SINGLE, FOLDED SHEET THAT OBSCURES DIRECT VISIBILITY OF THE PAD. 6. OR STAFF NOT INFORMED BY MEGADYNE DISTRIBUTOR REGARDING SAFETY OF PRODUCT IN PEDIATRIC PTS < 25 LBS. FINDINGS: IT IS POSSIBLE THAT THIS PT ACTUALLY MADE DIRECT CONTACT WITH THE MEGA 2000 PAD AT THE BILATERAL BUTTOCKS REGION. NOTE: IT IS UNCLEAR IF THE MOISTURE (INCONTINENCE OF URINE) WAS A FACTOR IN THE ELECTRICAL CONDUCTION OR OCCURRED AS A RESULT OF THE ALTERNATIVE PATHWAY CURRENT. 7. OR STAFF NOT INFORMED BY MEGADYNE DISTRIBUTOR REGARDING SAFETY OF PRODUCT IF DISTANCE BETWEEN THE PT AND PAD IS INCREASED (IE PLASTIC NECK TRAY T&A'S, PILLOWS, TOWEL ROLLS, GEL PADS, ETC). 8. SIMILAR INCIDENTS HAVE OCCURRED AT ANOTHER HOSP WITH USE OF THE MEGA 2000 PAD. THAT FACILITY HAS REVERTED BACK TO THE USE OF DUAL FOIL, DISPOSABLE DISPERSIVE ELECTRODE PADS. HYPOTHESIS: DURING PLACEMENT ON THE PT, LESS CONTACT BETWEEN THE PAD AND THE PT ACTUALLY OCCURRED - PAD IS COVERED BY A FOLDED SHEET. THE WEIGHT BEARING POINT OF CONTACT WAS AT THE BUTTOCKS REGION ONLY DUE TO ELEVATION OF THE PT'S HEAD, NECK AND SHOULDERS AWAY FROM THE MEGA 2000 PAD (INCREASED IMPEDANCE) DURING THE PROCEDURE. WHEN THE ESU WAS ACTIVATED FOR CAUTERY AND CUT, INEFFECTIVE. BURN OCCURRED AT THE SURGERY SITE DUE TO THE INABILITY OF THE PAD TO PROVIDE ADEQUATE CAPACITANCE RELATIVE TO THE LIMITED SURFACE AREA CONTACT. THEREFORE, AS ELECTRICAL CHARGE ENERGY IS DISCHARGED AT THE SKIN SURFACE, HEAT IS RELEASED. HEAT IN THE PRESENCE OR ABSENCE OF ACIDIC URINE RESULTED IN PARTIAL THICKNESS CHEMICAL BURNS AT THE MAXIMUM POINTS OF WEIGHT-BEARING (ISCHIAL TUBEROSITIES) AND SHORTEST ALTERNATIVE PATHWAY FOR ELECTRICAL CURRENT TO EXIT. CONCLUSIONS: IT IS LESS SAFE TO USE AN ESU SYSTEM IF UNABLE TO MONITOR RETURN ELECTRODE CONTINUOUS QUALITY MONITORING (RECQM) DURING A MONOPOLAR PROCEDURE OR ACTIVE ELECTRODE MONITORING (AEM) DURING A BIPOLAR PROCEDURE. THEREFORE, AN ESU UNIT THAT IS SWITCHED TO SINGLE FOIL MODE (SINGLE FOIL DISPOSABLE ELECTRODE OR MEGA 2000 REUSABLE ELECTRODE) DOES NOT PROVIDE THIS SAFETY CHECK 2,3. EVENTHOUGH THE REFERENCE ARTICLE INDICATES THE RECQM IS UNNECESSARY WITH THE MEGA 2000 PAD, IT BYPASSES THE SAFETY OF THE PT INTEGRITY AND CONTACT AREA DURING ESU OPERATION. RPTR AGREES THAT IT IS UNLIKELY THAT THE PT RECEIVED BURNS FROM THE MEGA 2000 PAD, SINCE THERE IS NO DIRECT CONTACT: SEPARATION BY FOLDED SHEET, PJ BOTTOMS, UNDER PANTS AND CLEAR PLASTIC, DISPOSABLE SHEATH.