THUNDERBEAT Open Fine Jaw TB-0009OFRecalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 04953170343346), received between Mar 12, 2018 and May 29, 2025 — classified as 13 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Break” (25 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 63 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2025Naturally Worn; Activation Problem; Naturally Worn; Activation Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE THUNDERBEAT OPEN FINE JAW EXHIBITED THE TISSUE PAD IN THE GRASPING SECTION WAS WORN AWAY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22105471 ↗
• MalfunctionMar 31, 2025Separation Problem; Separation Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE POLYMER LINING ON THE SINGLE USE THUNDERBEAT DEVICE HAD COME OFF. STILL ATTACHED TO PART OF THE DEVICE. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21734077 ↗
• InjuryNov 4, 2024Output Problem; Output Problem

  IT WAS REPORTED THAT DURING A POSTERIOR SEGMENTAL RESECTION (PARTIAL RESECTION OF THE POSTERIOR REGION OF THE LATERAL LIVER REGION) PROCEDURE, THE FIRST THUNDERBEAT DEVICE WAS USED AND GENERATED AN ERROR U508 AFTER 5-6 OUTPUTS. A SECOND DEVICE WAS USED AND FROM THE SAME LOT, AND U508 ERROR OCCURRED AFTER THREE SECONDS OR MORE OF OUTPUT. THE GENERATOR WAS REPLACED, AND THEN NEW TRANSDUCER WAS OPENED AND TRIED BUT THE ERROR STILL OCCURRED. AS SUCH, THE PROCEDURE WAS EXTENDED BY ABOUT AN HOUR FROM THE SCHEDULED TIME DUE TO THE STAFF NEEDING TO GO TO THE FACILITY AFTER THE ERROR OCCURRED. THE PROCEDURE WAS CONTINUED WHILE MAKING SURE THERE WAS NO OUTPUT FOR MORE THAN THREE SECONDS WHILE THE SECOND DEVICE WAS MALFUNCTIONING. NO ADDITIONAL ANESTHESIA OR TREATMENT WAS REQUIRED. THE PROCEDURE WAS COMPLETED USING THE SECOND DEVICE OF THE SAME MODEL. NO HEALTH CONSEQUENCES WERE REPORTED. THIS COMPLAINT IS RELEVANT TO THE SECOND DEVICE USED TO COMPLETE THE PROCEDURE THAT REPORTEDLY MALFUNCTIONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20599656 ↗
• InjuryNov 4, 2024Output Problem; Output Problem

  IT WAS REPORTED THAT DURING A POSTERIOR SEGMENTAL RESECTION (PARTIAL RESECTION OF THE POSTERIOR REGION OF THE LATERAL LIVER REGION) PROCEDURE, THE FIRST THUNDERBEAT DEVICE WAS USED AND GENERATED AN ERROR U508 AFTER 5-6 OUTPUTS. A SECOND DEVICE WAS USED AND FROM THE SAME LOT, AND U508 ERROR OCCURRED AFTER THREE SECONDS OR MORE OF OUTPUT. THE GENERATOR WAS REPLACED, AND THEN NEW TRANSDUCER WAS OPENED AND TRIED BUT THE ERROR STILL OCCURRED. AS SUCH, THE PROCEDURE WAS EXTENDED BY ABOUT AN HOUR FROM THE SCHEDULED TIME DUE TO THE STAFF NEEDING TO GO TO THE FACILITY AFTER THE ERROR OCCURRED. THE PROCEDURE WAS CONTINUED WHILE MAKING SURE THERE WAS NO OUTPUT FOR MORE THAN THREE SECONDS WHILE THE SECOND DEVICE WAS MALFUNCTIONING. NO ADDITIONAL ANESTHESIA OR TREATMENT WAS REQUIRED. THE PROCEDURE WAS COMPLETED USING THE SECOND DEVICE OF THE SAME MODEL. NO HEALTH CONSEQUENCES WERE REPORTED. THE COMPLAINT IS RELEVANT TO THE FIRST DEVICE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20599644 ↗
• InjuryJun 18, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A NECK DISSECTION, THE SUBJECT DEVICE'S COATING OF THE OPEN FINE JAW WAS DEFECTIVE AND SPARKS APPEARED DURING USAGE. IT WAS REPORTED THE PARTS CAME LOOSE OFF INTO THE PATIENT AND THEY WERE RECOVERED. THE PROCEDURE WAS COMPLETED WITH A SIMILAR PRODUCT. IT WAS STATED THAT WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA, THERE WAS NO RELEVANT PROLONGATION, ONLY A SHORT DELAY TO CHANGE THE DEVICE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19563778 ↗
• MalfunctionMar 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE ULTRASONIC SURGICAL DEVICE EXHIBITED A NON-INSULATED PART FALLING OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18992293 ↗
• MalfunctionJan 25, 2024Break; Break

  THE CUSTOMER REPORTED THE THUNDERBEAT OPEN FINE JAW BROKE OUTWARD FROM THE VICINITY OF THE BASE OF THE GRIP. THE ISSUE OCCURRED AFTER USING THE DEVICE FOR ABOUT TWO HOURS DURING A THERAPEUTIC NECK DISSECTION PROCEDURE. THE BROKEN GRIP FELL OFF ON THE INSTRUMENT TABLE. IF THEY TRIED TO REMOVE THE END VASCULAR CLIP THAT CLAMPED THE BLOOD VESSEL WITH THE DEVICE, THE ELASTICITY OF THE CLIP WOULD LOSE DURABILITY OF THE JAW AND BE DEFORMED. SINCE THE ISSUE OCCURRED TOWARDS THE END OF THE PROCEDURE, AN ELECTRIC KNIFE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18579895 ↗
• InjurySep 21, 2023Break; Break

  THE CUSTOMER REPORTED THE BIPOLAR JAW OF THE THUNDERBEAT OPEN FINE JAW BROKE WITHOUT REASON. THE ISSUE OCCURRED DURING A PROCEDURE. THE BROKEN TIP WAS TAKEN OUT OF THE PATIENT'S BODY BY GRASPING IT. A SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17792700 ↗
• InjurySep 21, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT PART OF THE UPPER JAW OF THE THUNDERBEAT OPEN FINE JAW BROKE WITHOUT ANY REASON. THE ISSUE OCCURRED DURING A THERAPEUTIC THYROIDECTOMY PROCEDURE. THE FUNCTIONAL MODE WAS SEAL AND CUT MODE 1. THE BROKEN PART WAS TAKEN OUT BY GRASPING IT FROM THE PATIENT'S BODY. THE UPPER JAW CONTAINED THE PAD AS WELL AND THEY EXPECTED THE PAD WAS ALSO DAMAGED. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17791981 ↗
• InjurySep 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE BIPOLAR JAW OF THE THUNDERBEAT OPEN FINE JAW BROKE WITHOUT ANY REASON. THE ISSUE OCCURRED DURING A THERAPEUTIC TTL MASTECTOMY PROCEDURE. THE CUSTOMER TOOK OUT A BROKEN TIP BY GRASPING IT FROM THE PATIENT'S BODY. A SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE WAS INSPECTED PRIOR TO USE AND NO ABNORMALITIES WERE FOUND. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17791817 ↗
• MalfunctionSep 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE TIP OF THE THUNDERBEAT OPEN FINE JAW WAS DAMAGED DURING A THERAPEUTIC LIVER RESECTION PROCEDURE AND IT BECAME IMPOSSIBLE TO OUTPUT. IT WAS UNKNOWN IF ANY ERROR MESSAGES WERE DISPLAYED. A SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE. WHEN CHECKING THE DEVICE, THE TIP COVER OF THE PROBE WAS DAMAGED AND PEELED OFF. THE PART HAD NOT FALLEN OUT OF THE BODY AND HAD BEEN PULLED UP. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17791704 ↗
• MalfunctionSep 20, 2023Fracture; Fracture

  A CUSTOMER REPORTED TO OLYMPUS, A PHYSICIAN WAS USING THE THUNDEBEAT OPEN FINE CLAW 9 CENTIMETER HANDPIECE CONSUMABLES AND ENCOUNTERED SOME PROBLEMS. THE DEVICE STARTED TO ALARM, AND THE SURGEON REALIZED THE TIP OF THE THUNDERBEAT HAD DISLODGED. WHEN THE SECOND THUNDERBEAT ALSO EXPERIENCED THIS SAME EVENT; THE THERAPEUTIC HAEMORRHOIDECTOMY WAS COMPLETED USING A REPLACEMENT DEVICE (HARMONIC). AFTER THE FIRST EVENT, THE SCRUB NURSE PUT THE DISLODGED TIP BACK TO SEE IF THERE WAS ANY MISSING PART. IT WAS CONFIRMED THAT NOTHING WENT INTO THE PATIENT¿S BODY FROM EITHER THUNDERBEATS. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS DEVICE. RELATED PATIENT IDENTIFIER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17785203 ↗
• MalfunctionSep 20, 2023Fracture; Peeled/Delaminated; Material Separation; Fracture; Peeled/Delaminated; Material Separation

  A CUSTOMER REPORTED TO OLYMPUS, A PHYSICIAN WAS USING THE THUNDERBEAT OPEN FINE CLAW 9 CENTIMETER HANDPIECE CONSUMABLES AND ENCOUNTERED SOME PROBLEMS. THE DEVICE STARTED TO ALARM, AND THE SURGEON REALIZED THE TIP OF THE THUNDERBEAT HAD DISLODGED. WHEN THE SECOND THUNDERBEAT ALSO EXPERIENCED THIS SAME EVENT; THE THERAPEUTIC HAEMORRHOIDECTOMY WAS COMPLETED USING A REPLACEMENT DEVICE (HARMONIC). AFTER THE FIRST EVENT, THE SCRUB NURSE PUT THE DISLODGED TIP BACK TO SEE IF THERE WAS ANY MISSING PART. IT WAS CONFIRMED THAT NOTHING WENT INTO THE PATIENT¿S BODY FROM EITHER THUNDERBEATS. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS DEVICE. RELATED PATIENT IDENTIFIER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17783941 ↗
• MalfunctionApr 28, 2023Material Separation; Material Separation

  THE CUSTOMER PROVIDED ADDITIONAL INFORMATION ON 31-MAY-2023: THE CUSTOMER REPORTED NO DELAY OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16832174 ↗
• MalfunctionApr 5, 2023Material Separation; Material Separation

  AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF A CUSTOMER, DURING AN OPERATION, THE THUNDERBEAT TISSUE PAD CAME OFF AND ERROR U504 (PROBE BREAK). THE PROCEDURE WAS A THERAPEUTIC FEMORAL TUMOR RESECTION. THE PRODUCT WAS COMPLETED USING A REPLACEMENT DEVICE. THERE WAS NO REPORT OF A DELAY, NO ADDITIONAL ANESTHESIA WAS REQUIRED, OR PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16682202 ↗
• MalfunctionMar 20, 2023Fracture; Fracture

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, IN THE MIDDLE OF A THERAPEUTIC ORTHOPEDIC PROCEDURE, THE DEVICE PROBE BROKE OFF AT THE BASE. THE BROKEN PIECE WAS RECOVERED. ERROR MESSAGE U504 PROBE DAMAGE WAS RECEIVED FOR THE DEVICE. PROCEDURE WAS COMPLETED WITH A NEW DEVICE OF THE SAME MODEL NUMBER WITH A DELAY. THE PATIENT DID NOT NEED ADDITIONAL ANESTHESIA. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT. TOTAL OPERATING TIME OF THE PROCEDURE IS BETWEEN TWO TO FIVE HOURS. THE INTELLIGENT TISSUE MONITORING (ITM) SETTING WAS ON DURING THE PROCEDURE. SETTINGS AT THE TIME OF THE EVENT WERE SEAL AND CUT 1, SEAL 1. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ANOMALY NOTED. THE CONNECTIONS TO THE GENERATOR WERE CHECKED. THE TRANSDUCER CORDS AND OTHER MEDICAL DEVICE CORDS WERE NOT BUNDLED TOGETHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16575396 ↗
• MalfunctionFeb 23, 2023Material Separation; Material Separation

  THE DEVICE WAS RETURNED FOR EVALUATION BY THE DISTRIBUTOR FOR WEAR OF TISSUE PAD DURING USE IN A THERAPEUTIC MAMMARY GLAND SURGERY. AFTER APPROXIMATELY TWO TO THREE OUTPUTS OF THE DEVICE FREQUENT ERROR MESSAGES WERE OBSERVED FOR THE DEVICE. THE TRANSDUCER WAS REPLACED; HOWEVER, THE ERROR MESSAGES CONTINUED. THE DEVICE WAS THEN REPLACED WITH A NEW DEVICE OF THE SAME MODEL NUMBER AND PROCEDURE COMPLETED WITHOUT ANY DELAY. THE TISSUE PAD WAS NOTED TO HAVE WEAR. THE PATIENT DID NOT NEED ADDITIONAL ANESTHESIA. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT. THE INTELLIGENT TISSUE MONITORING (ITM) SETTING WAS ON DURING THE PROCEDURE. THE SETTINGS ARE SEAL AND CUT 1, SEAL 3. THE DEVICE WAS INSPECTED PRIOR TO SUE WITH NO ANOMALY NOTED. THE CONNECTIONS TO THE GENERATOR WERE CHECKED. THE TRANSDUCER CORDS AND OTHER MEDICAL DEVICE CORDS WERE NOT BUNDLED TOGETHER. UPON EVALUATION OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THERE WAS SEVERE WEAR OF THE TISSUE PAD AT THE TIP WHERE THERE WAS CONTACT WITH THE TIP OF THE PROBE. THIS MEDWATCH IS BEING SUBMITTED FOR THE REPORTABLE ISSUE OF SEVERE WEAR OF THE TISSUE PAD AS OBSERVED DURING DEVICE EVALUATION. THE DOCTOR USING THE DEVICE IN THE PROCED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16426839 ↗
• MalfunctionJan 19, 2023Thermal Decomposition of Device; Thermal Decomposition of Device

  THE CUSTOMER REPORTED TO OLYMPUS THAT WHILE USING THE THUNDERBEAT OPEN FINE JAW, THE TISSUE PAD BURNT AND DETACHED FROM THE TIP WHILE PERFORMING COAGULATION. THE ISSUE OCCURRED DURING THE THERAPEUTIC PROCEDURE, AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16203674 ↗
• MalfunctionDec 21, 2022Break; Break

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING A THERAPEUTIC LAPAROSCOPIC LOBECTOMY PROCEDURE, THE DEVICE PROBE TIP BROKE OFF AND FELL INTO THE PATIENT BODY. THE BROKEN PIECE WAS IMMEDIATELY REMOVED FROM THE PATIENT BODY. THEREAFTER, THE PROCEDURE WAS COMPLETED NORMALLY WITHOUT ANY DELAY WITH A NEW SIMILAR DEVICE FROM THE SAME LOT, WHICH WAS IN STOCK. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT. THE FUNCTIONAL MODE AT THE TIME OF THE EVENT WAS SEAL AND CUT MODE. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ABNORMALITY NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16028724 ↗
• MalfunctionDec 9, 2022Degraded; Peeled/Delaminated; Degraded; Peeled/Delaminated

  THE CUSTOMER REPORTED THAT THE PROBE ON THE SUBJECT DEVICE WAS DAMAGED DURING A THYROIDECTOMY PROCEDURE. ERROR MESSAGE U509 (ULTRASONIC LEVEL ERROR) OCCURRED AFTER SEVERAL ROUNDS OF SEALING HAD BEEN DONE BY THE SURGEON. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE FROM ANOTHER MANUFACTURER. THE SUBJECT DEVICE WAS SENT TO OLYMPUS FOR EVALUATION. DURING INSPECTION AND TESTING, THE TISSUE PAD WAS WORN OUT AND PARTIALLY PEELED OFF. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION (TISSUE PAD PEELING). THERE WAS NO EFFECT ON THE PATIENT DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15952826 ↗
• MalfunctionDec 7, 2022Peeled/Delaminated; Peeled/Delaminated

  ADDENDUM JAN 24, 2023: THE PATIENT DID NOT NEED TO BE GIVEN ADDITIONAL ANESTHESIA FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15934196 ↗
• MalfunctionDec 2, 2022Break; Break

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, AFTER APPROXIMATELY TWO TO THREE USES OF THE DEVICE IN A THERAPEUTIC LOBECTOMY PROCEDURE THE DEVICE TIP BROKE OFF AND FELL INTO THE PATIENT. THE BROKEN PIECE WAS REMOVED IMMEDIATELY. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES WITH A NEW DEVICE THAT WAS IN STOCK. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT. FUNCTIONAL MODE AT THE TIME OF THE EVENT WAS SEAL AND CUT MODE. THE DEVICE WAS INSPECTED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15903326 ↗
• MalfunctionNov 9, 2022Break; Break

  ADDENDUM NOV 28, 2022: THE BROKEN PIECE FELL IN THE PATIENT AND WAS IMMEDIATELY RETRIEVED BY MEDICAL STAFF. EVENT OCCURRED IN THE BEGINNING OF THE PROCEDURE WHEN THE DOCTOR WAS PERFORMING SEAL AND CUT MODE. DELAY IN THE PROCEDURE WAS ONLY FOR THE TIME NEEDED TO OPEN A NEW DEVICE THAT WAS IN STOCK. IT IS NOT KNOWN IF ANY ERROR MESSAGE WAS RECEIVED FOR THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15763952 ↗
• MalfunctionAug 23, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTS DURING AN UNSPECIFIED PROCEDURE USING A THUNDERBEAT, THE PROBE BROKE DURING OPERATION AND WAS RECOVERED. THE PROCEDURE WAS COMPLETED WITH A SECOND THUNDERBEAT. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE. SETTINGS BEING USED DURING THE PROCEDURE: SEAL & CUT; CUT (LEVEL 1), SEAL (LEVEL 3) ADDITIONAL DETAILS REGRADING THE PATIENT AND REPORTED EVENT HAVE BEEN REQUESTED. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15276971 ↗
• InjuryJul 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED "THE USE OF HARMONIC FOCUS AND THUNDERBEAT OPEN FINE JAW IN THYROID SURGERY: EXPERIENCE OF A HIGH-VOLUME CENTER," PATIENTS EXPERIENCED ADVERSE EVENTS AFTER PROCEDURES USING THUNDERBEAT OPEN FINE JAW. BACKGROUND: IN THYROID SURGERY, ACHIEVING ACCURATE HEMOSTASIS IS FUNDAMENTAL IN ORDER TO AVOID THE OCCURRENCE OF COMPLICATIONS. ENERGY-BASED DEVICES ARE CURRENTLY EXTENSIVELY UTILIZED IN THIS FIELD OF SURGERY. THIS STUDY AIMS TO COMPARE HARMONIC FOCUS AND THUNDERBEAT OPEN FINE JAW WITH REGARD TO SURGICAL OUTCOMES AND COMPLICATIONS. METHODS: PATIENTS SUBMITTED TO TOTAL THYROIDECTOMY IN OUR CENTER, BETWEEN JANUARY 2017 AND JUNE 2020, WERE RETROSPECTIVELY ANALYZED. BASED ON THE ENERGY-BASED DEVICE UTILIZED, TWO GROUPS WERE IDENTIFIED: GROUP A (HARMONIC FOCUS) AND GROUP B (THUNDERBEAT OPEN FINE JAW). RESULTS: A TOTAL OF 527 PATIENTS WERE INCLUDED: 409 IN GROUP A AND 118 IN GROUP B. ABOUT SURGICAL OUTCOMES, THE MEAN OPERATIVE TIME WAS SIGNIFICANTLY SHORTER IN GROUP B THAN IN GROUP A (P < 0.001), WHILE AS REGARDS COMPLICATIONS, THE OCCURRENCE OF TRANSIENT RECURRENT LARYNGEAL NERVE INJURY WAS SIGNIFICANTLY GREATER IN GROUP B THAN IN GROUP A (P = 0.019).

  Patient problems: Hematoma; Post Operative Wound Infection

  MAUDE report 14888090 ↗