BOVIE MEDICAL
Report
- Report Number
- 3007208013-2024-00020
- Event Type
- Injury
- Date Received
- May 24, 2024
- Report Date
- October 8, 2024
- Manufacturer
- SYMMETRY SURGICAL INC.
- Product Code
- GEI
- PMA / PMN Number
- K134054
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE COMPLAINANT ALLEGES THAT THE REPORTED DEVICE WAS USED IN A TOTAL HIP REPLACEMENT SURGERY. BASED ON THE INFORMATION RECEIVED FROM THE CUSTOMER THE COMPLAINT CASE WAS ABLE TO BE CONFIRMED. THE REPORTED DEVICE WAS RETURNED TO THE MANUFACTURER AND INSPECTED. THE REPORTED DEVICE WAS RECEIVED ON 05/01/2024 AND RECEIVED FOR REPAIR PROCESSING ON 05/02/2024. THE REPORTED DEVICE WAS INSPECTED TO FIND POWER SETTINGS AT CUT1 70=74, PINPOINT 50=53, AND MACRO 25=28. DURING INITIAL TESTING FOR HYPOT AND LEAKAGE TESTING, NO ISSUES WERE FOUND WITH THE REPORTED DEVICE. THE UNIT WAS THEN SUBJECTED TO TESTING PER INTERNAL WORK INSTRUCTIONS WHERE THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTING AND WAS CONFIRMED TO BE ACCEPTABLE FOR USE. A DHR REVIEW WAS COMPLETED FOR PRODUCT A2350 WITH SERIAL NUMBER (B)(6). THERE WERE NO NOTED NONCONFORMITIES DURING MANUFACTURING AND PROCESSING OF THIS PRODUCT AND LOT NUMBER. ALL ITEMS WERE NOTED AS WITHIN MANUFACTURING SPECIFICATION FROM THE MANUFACTURER. A TRUE ROOT CAUSE IS UNABLE TO BE DETERMINED BASED ON THE INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION IS OBTAINED THAT IS PERTINENT TO THE INVESTIGATION OR PROVIDES ADDITIONAL DETAILS A FOLLOW-UP REPORT WILL BE PROVIDED. UNTIL SUCH TIME, THIS CAN BE SEEN AS THE FINAL REPORT.
THE COMPLAINANT ALLEGES THAT THE REPORTED DEVICE WAS USED IN A TOTAL HIP REPLACEMENT SURGERY. BASED ON THE INFORMATION RECEIVED FROM THE CUSTOMER THE COMPLAINT CASE WAS ABLE TO BE CONFIRMED. THE REPORTED DEVICE WAS RETURNED TO THE MANUFACTURER AND INSPECTED. THE REPORTED DEVICE WAS RECEIVED ON 05/01/2024 AND RECEIVED FOR REPAIR PROCESSING ON 05/02/2024. THE REPORTED DEVICE WAS INSPECTED TO FIND POWER SETTINGS AT CUT1 70=74, PINPOINT 50=53, AND MACRO 25=28. DURING INITIAL TESTING FOR HYPOT AND LEAKAGE TESTING, NO ISSUES WERE FOUND WITH THE REPORTED DEVICE. THE UNIT WAS THEN SUBJECTED TO TESTING PER INTERNAL WORK INSTRUCTIONS WHERE THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTING AND WAS CONFIRMED TO BE ACCEPTABLE FOR USE. A DHR REVIEW WAS COMPLETED FOR PRODUCT A2350 WITH SERIAL NUMBER AA2423003. THERE WERE NO NOTED NONCONFORMITIES DURING MANUFACTURING AND PROCESSING OF THIS PRODUCT AND LOT NUMBER. ALL ITEMS WERE NOTED AS WITHIN MANUFACTURING SPECIFICATION FROM THE MANUFACTURER. A TRUE ROOT CAUSE IS UNABLE TO BE DETERMINED BASED ON THE INFORMATION AVAILABLE. ON (B)(6) 2024 - A CALL WAS HOSTED WITH THE PHYSICIAN WHERE IT AS CONFIRMED THAT THE PATEINT EXHIBITED CARDIAC ARRHYTHMIA. IF ADDITIONAL INFORMATION IS OBTAINED THAT IS PERTINENT TO THE INVESTIGATION OR PROVIDES ADDITIONAL DETAILS A FOLLOW-UP REPORT WILL BE PROVIDED. UNTIL SUCH TIME, THIS CAN BE SEEN AS THE FINAL REPORT.
THE COMPLAINANT ALLEGES, "SHORTLY AFTER BEGINNING PATIENT'S RIGHT TOTAL HIP PROCEDURE, PATIENT WENT INTO ASYSTOLE. A CODE WAS CALLED. THE CHARGE NURSE ENTERED THE ROOM IMMEDIATELY AND WAS INSTRUCTED TO GET THE CRASH CART. COMPRESSIONS STARTED AT THIS TIME AND MEDICATION WERE BEING GIVEN. THE CORDS/BOVIE PEN AND GROUNDING PAD WERE PULLED OUT OF THE MACHINE. AT THIS TIME, PATIENT SPONTANEOUSLY REBOUNDED FROM ASYSTOLE TO NORMAL SINUS RHYTHM. A NEW BOVIE MACHINE WAS BROUGHT IN, NEW PEN AND GROUNDING PAD WERE UTILIZED. NO FURTHER INCIDENTS FOR REMAINDER OF CASE. FOR REFERENCE, THE SPONTANEOUS RETURN OF SINUS RHYTHM OCCURRED BEFORE RX COULD CIRCULATE VIA COMPRESSION AND WAS ALMOST SIMULTANEOUS WITH THE BOVIE BEING UNPLUGGED."
THE COMPLAINANT ALLEGES, "SHORTLY AFTER BEGINNING PATIENT'S RIGHT TOTAL HIP PROCEDURE, PATIENT WENT INTO ASYSTOLE. A CODE WAS CALLED. THE CHARGE NURSE ENTERED THE ROOM IMMEDIATELY AND WAS INSTRUCTED TO GET THE CRASH CART. COMPRESSIONS STARTED AT THIS TIME AND MEDICATION WERE BEING GIVEN. THE CORDS/BOVIE PEN AND GROUNDING PAD WERE PULLED OUT OF THE MACHINE. AT THIS TIME, PATIENT SPONTANEOUSLY REBOUNDED FROM ASYSTOLE TO NORMAL SINUS RHYTHM. A NEW BOVIE MACHINE WAS BROUGHT IN, NEW PEN AND GROUNDING PAD WERE UTILIZED. NO FURTHER INCIDENTS FOR REMAINDER OF CASE. FOR REFERENCE, THE SPONTANEOUS RETURN OF SINUS RHYTHM OCCURRED BEFORE RX COULD CIRCULATE VIA COMPRESSION AND WAS ALMOST SIMULTANEOUS WITH THE BOVIE BEING UNPLUGGED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 623682 | BOVIE MEDICAL | HIGH FREQUENCY ELECTROSURGICAL GENERATOR | GEI | SYMMETRY SURGICAL INC. | A2350 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |