SONICBEAT 5 mm, 20 cm, Front-actuated Grip SB-0520FCRecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 04953170370601), received between Jul 3, 2018 and Nov 1, 2024 — classified as 3 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Material Separation” (13 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 1, 2024Material Separation; Material Separation

  IT WAS REPORTED THE SONICBEAT TISSUE PAD CAME OFF AND LOOKED LIKE IT WAS ABOUT TO FALL OFF AFTER ONE HOUR OF USE. THE ISSUE OCCURRED DURING A THERAPEUTIC INGUINAL HERNIA PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20586858 ↗
• MalfunctionOct 15, 2024Break; Break

  IT WAS REPORTED THAT, IMMEDIATELY AFTER THE START OF THE PARTIAL LIVER RESECTION (THERAPEUTIC LAPAROTOMY PROCEDURE), THE TISSUE PAD OF THE ULTRASONIC SURGICAL INSTRUMENT BROKE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20450854 ↗
• MalfunctionSep 24, 2024Degraded; Degraded

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE COLONOVIDEOSCOPE EXHIBITED THE TISSUE PAD HAD EXPOSURE OF METAL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20293487 ↗
• MalfunctionSep 18, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT AFTER PRINTING, THE TISSUE PAD APPEARED TO BE WARPED. IT WAS UNCLEAR HOW MANY TIMES IT OCCURRED AFTER PRINTING. THE ISSUE OCCURRED DURING A THERAPEUTIC THORACIC SURGERY. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20250263 ↗
• MalfunctionSep 13, 2024Material Separation; Material Separation

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SONICBEAT 5 MM, 20 CM, FRONT-ACTUATED GRIP EXHIBITED ABRASION/METAL EXPOSURE OF THE TISSUE PAD. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20215227 ↗
• MalfunctionMay 7, 2024Material Separation; Material Split, Cut or Torn; Material Separation; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TISSUE PAD DID NOT FALL OFF INSIDE THE PATIENT. NO DELAY OR HEALTH HAZARDS WAS REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19263550 ↗
• InjuryMar 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "ENDOSCOPIC SURGERY FOR THYROID TUMORS INTRODUCTION OF ENDOSCOPIC THYROID SURGERY AT KUMA HOSPITAL". LITERATURE SUMMARY ENDOSCOPIC THYROID SURGERY CASES AT OUR HOSPITAL [TARGET] -PATIENTS WHO UNDERWENT ENDOSCOPIC THYROID SURGERY FROM MAY TO (B)(6) 2023. -THE NUMBER OF PATIENTS WAS 20. -ALL PATIENTS UNDERWENT VANS VIDEO-ASSISTED NECK SURGERY METHOD. -INTRAOPERATIVE NERVE MONITORING DEVICE WAS USED IN ALL CASES. -ENERGY DEVICES LIGASURE, SONIC BEAT, HARMONIC [RESULT] SURGICAL TIME -AVERAGE 194 MINUTES -WITHIN 3 MONTHS AFTER START: 286 MINUTES (1-6 CASES) -LESS THAN 4 MONTHS: 155 MINUTES (7-20 CASES) BLEEDING VOLUME -AVERAGE 29ML -WITHIN 3 MONTHS AFTER START: 42 ML (1-6 CASES) -LESS THAN 4 MONTHS: 15 ML (7-20 CASES) COMPLICATIONS -POSTOPERATIVE VOCAL CORD PARALYSIS: 3 CASES ONE CASE OF THERMAL INJURY DUE TO STEAM HEAT FROM AN ENERGY DEVICE HOARSENESS RECOVERED AFTER 6 MONTHS -POSTOPERATIVE BLEEDING: 0 CASES -CONVERSION TO EXTERNAL INCISION: 0 CASE -POSTOPERATIVE SUBCUTANEOUS SEROMA: 1 CASE (RELIEVED BY PUNCTURE DRAINAGE) TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS POSTOPERATIVE VOCAL CORD PARALYSIS (N=3) POSTOPERATIVE SUB

  Patient problems: Paralysis; Seroma

  MAUDE report 18962538 ↗
• MalfunctionMar 7, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE TISSUE PADS ON BOTH SONICBEATS WERE BURNED AND PEELED OFF DURING THE LIVER RESECTION LAPAROTOMY PROCEDURE. THE PROCEDURE WAS COMPLETED USING A THIRD DEVICE. THE CUSTOMER REPORTED THAT THE TISSUE PADS WERE WORN OUT AND DID NOT FALL OFF INSIDE THE BODY. AS SUCH, THE PROCEDURE WAS DELAYED (UNSPECIFIED), AND NO ADDITIONAL ANESTHESIA WAS REQUIRED. THOUGH A DELAY WAS REPORTED, THERE WERE NO ADVERSE EVENTS OR ADVERSE CLINICAL IMPACTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18853637 ↗
• MalfunctionMar 7, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE TISSUE PADS ON BOTH SONICBEATS WERE BURNED AND PEELED OFF DURING THE LIVER RESECTION LAPAROTOMY PROCEDURE. THE PROCEDURE WAS COMPLETED USING A THIRD DEVICE. THE CUSTOMER REPORTED THAT THE TISSUE PADS WERE WORN OUT AND DID NOT FALL OFF INSIDE THE BODY. AS SUCH, THE PROCEDURE WAS DELAYED (UNSPECIFIED), AND NO ADDITIONAL ANESTHESIA WAS REQUIRED. THOUGH A DELAY WAS REPORTED, THERE WERE NO ADVERSE EVENTS OR ADVERSE CLINICAL IMPACTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18853609 ↗
• MalfunctionDec 26, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE INSTRUMENT'S TISSUE PAD WAS WORN OUT DURING A THERAPEUTIC OPEN LIVER RESECTION PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT DEVICE; THERE WAS NO REPORT OF DELAY OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18395445 ↗
• MalfunctionDec 21, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE INSTRUMENT'S TISSUE PAD WORE OUT AND THE METAL WAS VISIBLE DURING A THERAPEUTIC LAPAROTOMY PROCEDURE; IT MADE THE INSTRUMENT UNUSABLE DUE TO FREQUENT ERRORS. THE DEVICE WAS REPLACED WITH A NEW ONE, AND THE PROCEDURE WAS COMPLETED WITH NO DELAY. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18370689 ↗
• MalfunctionNov 22, 2023Degraded; Degraded

  THE CUSTOMER REPORTED A SHORT CIRCUIT OCCURRED WITH THE SONICBEAT FRONT-ACTUATED GRIP. THE ISSUE OCCURRED DURING A THERAPEUTIC GASTRECTOMY PROCEDURE. ANOTHER DEVICE WAS USED AND THE PROCEDURE WAS COMPLETED NORMALLY WITHOUT DELAY. THE DEVICE WAS INSPECTED PRIOR TO USE AND THERE WERE NO ISSUES. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT. DURING DEVICE EVALUATION AT OLYMPUS, IT WAS FOUND THE PAD WAS WORN WITH METAL EXPOSED. THE REPORT IS BEING SUBMITTED DUE TO DEFECT FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18193759 ↗
• InjuryAug 9, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE SONICBEAT 5 MM, 20 CM, FRONT-ACTUATED GRIP PROBE BROKE UPON ACTIVATION WHEN IT TOUCHED METAL DURING A THERAPEUTIC EXCISION OF THYROID NODULES. THE PROBE FELL INSIDE THE PATIENT AND WAS RETRIEVED IMMEDIATELY. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. IT WAS ALSO NOTED THAT THIS DISPOSABLE DEVICE WAS REPROCESSED BY THE FACILITY AND REUSED. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17493886 ↗
• MalfunctionAug 2, 2023Material Separation; Material Separation

  A CUSTOMER REPORTED TO OLYMPUS DURING AN OPERATION, THE SONICBEAT TISSUE PAD DETACHED AT THE TIP. THE TISSUE PAD DID NOT FALL OFF AND NO ERROR WAS DISPLAYED. THE DOCTOR NOTICED THE EVENT AND STOPPED USING THE SUBJECT DEVICE. THE THERAPEUTIC VIDEO ASSISTED NECK SURGERY (VANS) WAS COMPLETED BY USING A REPLACEMENT DEVICE. THERE WAS NO REPORT OF A PROCEDURAL DELAY OR PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17445819 ↗
• MalfunctionJul 31, 2023Material Separation; Material Separation

  AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF A CUSTOMER, DURING A THERAPEUTIC RESPIRATORY SURGERY WHEN OUTPUT SEVERAL TIMES THE SONICBEAT TISSUE PAD GOT BURNT. AFTER RESECTING INTERCOSTAL MUSCLES TWICE, AND TRYING TO PEEL OFF THE MUCOUS MEMBER, IT WAS FOUND THAT THE TIP OF PAD HAD PEELED OFF. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT DEVICE. THERE WAS NO REPORT OF ADDITIONAL ANESTHESIA, A PROCEDURAL DELAY OR PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17430877 ↗
• MalfunctionJun 28, 2023Material Separation; Material Separation

  THE CUSTOMER REPORTED TO OLYMPUS THE SONICBEAT 5 MM, FRONT ACTUATED GRIP TISSUE PAD ROLLED UP AND BEGAN TO SEPARATE. THE ISSUE WAS FOUND DURING A THERAPEUTIC, THORACOSCOPIC PARTIAL RESECTION OF THE RIGHT MIDDLE LOBE OF THE LUNG TOWARDS THE BEGINNING OF THE PROCEDURE. THE DEVICE WAS REPLACED WITH A SIMILAR DEVICE WHICH WAS USED TO COMPLETE THE PROCEDURE, AND THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17218235 ↗
• MalfunctionJun 26, 2023Material Separation; Material Separation

  THE CUSTOMER REPORTED TO OLYMPUS THE SONICBEAT 5 MM, FRONT-ACTUATED GRIP HAD A TISSUE PAD WHICH WAS WORN OUT AND CAME OFF. THE ISSUE WAS FOUND DURING AN UNIDENTIFIED, THERAPEUTIC PROCEDURE THAT WAS COMPLETED WITH A SIMILAR DEVICE. WHEN THE TISSUE PAD CAME OFF, IT DID NOT ENTER THE PATIENT¿S BODY. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT FROM THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17204207 ↗
• InjuryJun 22, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS ON BEHALF OF THE CUSTOMER THAT AN ERROR (UNKNOWN CODE) WAS DISPLAYED WHILE THE SONICBEAT 5 MM, 20 CM, FRONT-ACTUATED GRIP SCISSORS WAS CONNECTED TO THE USG-400 DURING AN UNKNOWN PROCEDURE. AFTER WHICH, THE PROBE BROKE AND FELL OUT INTO THE PATIENT'S STOMACH. THE PROBE WAS RECOVERED DURING SURGERY. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO HEALTH HAZARD REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17187542 ↗
• MalfunctionJun 9, 2023Peeled/Delaminated; Peeled/Delaminated

  THE OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT DURING A LAPAROTOMY TOTAL GASTRECTOMY (THERAPEUTIC), AN ERROR OCCURRED DURING THE THIRD OUTPUT AND THE SONICBEAT 5 MM, 20 CM, FRONT-ACTUATED GRIP BECAME UNUSABLE. THE DEVICE WAS REPLACED WITH ANOTHER ONE OF THE SAME MODEL NUMBER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO HEALTH HAZARD TO THE PATIENT, NO PROCEDURAL DELAY, AND NO ADDITIONAL ANESTHESIA WAS NEEDED. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT. THE DEVICE WAS RETURNED AND EVALUATED, AND THE TISSUE PAD WAS WORN AND PARTIALLY PEELED OFF. THIS MDR IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17101040 ↗
• MalfunctionMay 9, 2023Material Separation; Material Separation

  THE CUSTOMER PROVIDED ADDITIONAL INFORMATION: PATIENT INFORMATION IS UNKNOWN. THE PROCEDURE WAS THORACIC SURGERY. NO HEALTH HAZARD. NO ADDITIONAL TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16895225 ↗
• MalfunctionMay 4, 2023Degraded; Degraded

  THE CUSTOMER REPORTED TO OLYMPUS, THAT DURING A THERAPEUTIC LAPAROSCOPIC CONVERSION FOR CHOLECYSTECTOMY SURGICAL PROCEDURE. SMOKE OCCURRED FROM THE SONICBEAT 5 MM, 20 CM, FRONT-ACTUATED GRIP, WITH AN ERROR MESSAGE AT THE OLYMPUS GENERATOR. THE ERROR MESSAGE E504 WAS PRESENTED. THE PLASTIC OF THE CLAMP MELTED. THE INTELLIGENT TISSUE MONITORING FUNCTIONALITY WAS TURNED ON. INSPECTION AND TESTING OF THE RETURNED DEVICE FOUND THE TISSUE PADS WERE SEVERELY WORN. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16870487 ↗
• MalfunctionMar 3, 2023Material Separation; Material Separation

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, IN THE MIDDLE OF A RESPIRATORY PROCEDURE TO REMOVE A MEDIASTINAL TUMOR WITH THORACOSCOPIC ASSISTANCE, THE TISSUE PAD OF THE DEVICE CAME OFF. THERE WAS NO ERROR MESSAGE RECEIVED. PROCEDURE WAS COMPLETED WITH A NEW DEVICE OF THE SAME MODEL NUMBER WITH A DELAY OR APPROXIMATELY THREE MINUTES NEEDED TO SWITCH THE DEVICES. THE PATIENT DID NOT NEED ADDITIONAL ANESTHESIA. TOTAL OPERATING TIME OF THE PROCEDURE IS BETWEEN TWO TO FIVE HOURS. THE INTELLIGENT TISSUE MONITORING (ITM) SETTING WAS ON DURING THE PROCEDURE. 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. SURGEON WAS SKILLED. THIS IS THE FIRST TIME SUCH AN EVENT OCCURRED WITH THIS USER. EVENT POSSIBLY OCCURRED DUE TO EXTENDED OUTPUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16478081 ↗
• MalfunctionDec 2, 2022Break; Degraded; Break; Degraded

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, 30 MINUTES INTO A THERAPEUTIC LAPAROTOMY PROCEDURE, AFTER THE USER OUTPUT THE DEVICE TWICE AN UNKNOWN ERROR MESSAGE OCCURRED AND THE DEVICE STOPPED OUTPUTTING. WHEN THE DEVICE WAS CHECKED, THE DEVICE PROBE BROKE OFF. THE TISSUE PAD WAS ALSO FOUND TO BE WORN. THE PROCEDURE WAS COMPLETED WITH A NEW SIMILAR DEVICE OF THE SAME MODEL NUMBER. THERE WAS NO DELAY IN THE COMPLETION OF THE PROCEDURE. THE PATIENT DID NOT NEED TO BE GIVEN ADDITIONAL ANESTHESIA. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT. TOTAL PROCEDURE TIME WAS TWO HOURS. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ANOMALY NOTED. THE CONNECTIONS TO THE GENERATOR WERE CHECKED. THIS IS THE FIRST TIME THE ISSUE OCCURRED WITH THE USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15903711 ↗
• MalfunctionNov 30, 2022Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER PROVIDED ADDITIONAL INFORMATION ON 13DEC2022: THE EVENT OCCURRED TOWARDS THE END OF THE PROCEDURE. THE FUNCTIONAL MODE AND SETTINGS AT THE TIME OF THE EVENT ARE NOT KNOWN. NO PART OF THE TISSUE PAD CAME OFF. THERE WAS MINIMAL DELAY TO THE COMPLETION OF THE PROCEDURE, JUST ENOUGH TO REPLACE THE DEVICE WITH A NEW ONE. THE PATIENT DID NOT NEED TO BE GIVEN ADDITIONAL ANESTHESIA. IT IS NOT KNOWN IF THERE WAS ANY ERROR MESSAGE OR ALARM RECEIVED FOR THE DEVICE AT THE TIME OF THE EVENT. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ANOMALY NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15890313 ↗
• MalfunctionFeb 16, 2022Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING A THERAPEUTIC TONSILLECTOMY, AFTER THE DEVICE WAS ACTIVATED TWO TO THREE TIMES, THE TIP OF THE PTFE PAD (TEFLON PAD) WAS PARTIALLY PEELED FROM THE UPPER JAW. THE TEFLON PAD WAS BURNED OVERALL AS WELL. THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE. THERE IS NO REPORTED HARM OR ADVERSE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13544420 ↗