UNK_ULTRACISION HARMONIC FOCUS
Report
- Report Number
- 3005075853-2025-04957
- Event Type
- Injury
- Date Received
- July 1, 2025
- Date of Event
- February 3, 2021
- Report Date
- July 1, 2025
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- LFL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
(B)(4). DATE SENT: 7/1/2025. B3: PUBLICATION YEAR OF 2021. D4: BATCH # UNK. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF PUBLISHED SCIENTIFIC ARTICLES CAPTURED UNDER CAPA-014204. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
TITLE: MACHINE LEARNING MODELS FOR PREDICTING FACIAL NERVE PALSY IN PAROTID GLAND SURGERY FOR BENIGN TUMORS. AUTHORS: CARLOS MIGUEL CHIESA-ESTOMBA, MD, MSC, OIER ECHANIZ, MSC, JON ALEXANDER SISTIAGA SUAREZ, MD, JOSE ANGEL GONZA´LEZ-GARCIA, MD, PHD,A EKHINE LARRUSCAIN, MD, MSC, XABIER ALTUNA, MD, PHD, ALFONSO MEDELA, MSC, AND MANUEL GRANA, PHD. CITATION: JOURNAL OF SURGICAL RESEARCH, JUNE 2021 (262) 57-64. THIS STUDY AIMED TO EVALUATE THE EFFECTIVENESS OF 4 POTENTIAL MACHINE LEARNING MODELS: K-NEAREST NEIGHBOR (KNN), RANDOM FOREST (RF), BOOSTED CLASSIFICATION (BC), AND LINEAR DISCRIMINANT CLASSIFICATION (LDC) FOR PREDICTING FACIAL NERVE INJURY IN PAROTID GLAND SURGERY FOR BENIGN TUMORS. BETWEEN JUNE 2010 AND JUNE 2019, 345 PATIENTS WITH A CLINICALLY AND RADIOLOGICALLY EVIDENT BENIGN TUMOR IN THE PAROTID GLAND WHO WERE TREATED SURGICALLY WERE INCLUDED IN THE STUDY. THERE WERE 192 MALES AND 153 FEMALES WITH A MEAN AGE OF 58 +/- 13.9 YEARS (MIN: 18/MAX: 87). DURING THE PROCEDURE, ONCE THE MAIN TRUNK OF THE FACIAL NERVE WAS IDENTIFIED, THE PAROTID TISSUE WAS DIVIDED USING A HARMONIC SCALPEL (HARMONIC FOCUS, ETHICON ENDO-SURGERY) OR A NON-ETHICON BIPOLAR CAUTERY. IN ALL CASES, THE FACIAL NERVE WAS MONITORED AND STIMULATED BEFORE AND AFTER RESECTION. AT THE END OF THE SURGERY, A COMPETITOR¿S VACUUM SUCTION DRAIN WAS ATTACHED. FACIAL NERVE FUNCTION WAS SYSTEMATICALLY ASSESSED IMMEDIATELY AFTER SURGERY AND THE DAY AFTER SURGERY. FACIAL NERVE FUNCTION WAS MEASURED DURING FOLLOW-UP IN ACCORDANCE WITH THE HOUSE-BRACKMANN SCALE. THE MEAN FOLLOW-UP PERIOD WAS 11 MONTHS (MINIMUM: 6/MAX: 24). THE REPORTED COMPLICATIONS INCLUDED TRANSIENT FACIAL PALSY (N=?) AND DEFINITIVE FACIAL PALSY (N=?). IN CONCLUSION, THIS STUDY DEMONSTRATES THAT MACHINE LEARNING PREDICTION MODELS CAN PROVIDE EVIDENCE-BASED PREDICTIONS ABOUT THE RISK OF FACIAL NERVE INJURY TO OTOLARYNGOLOGISTS AND PATIENTS. IT IS HOPED THAT SUCH ALGORITHMS, WHICH USE CLINICAL, RADIOLOGICAL, HISTOLOGICAL, AND CYTOLOGICAL INFORMATION, CAN IMPROVE THE INFORMATION GIVEN TO PATIENTS BEFORE SURGERY SO THAT THEY CAN BE BETTER INFORMED OF ANY POTENTIAL COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1430990 | UNK_ULTRACISION HARMONIC FOCUS | INSTRUMENT, ULTRASONIC SURGICAL | LFL | ETHICON ENDO-SURGERY, LLC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention | GENERATOR |