SONICBEAT 5 mm, 35 cm, Front-actuated Grip SB-0535FCRecalls & reported problems

Summary

The FDA's MAUDE database contains 379 adverse event reports that list this exact device (DI 04953170370540), received between Oct 10, 2017 and Sep 30, 2026 — classified as 31 injuries, 348 malfunctions.

The most frequently reported specific device problem is “Material Separation” (125 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 379 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break

  The customer returned the instrument to the service center for a separate issue. During the device analysis, the device evaluator indicated that the probe was broken off. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951670 ↗
• MalfunctionJun 24, 2026Peeled/Delaminated

  THE CUSTOMER RETURNED THE SONICBEAT SURGICAL INSTRUMENT TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING OLYMPUS¿ DEVICE ANALYSIS IT WAS INDICATED THAT THE SONICBEAT'S TISSUE GRASPING INSULATION PAD WAS PEELING OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25611943 ↗
• MalfunctionMay 29, 2026Degraded

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED THE TISSUE PAD IS SEVERELY WORN AWAY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25333995 ↗
• MalfunctionFeb 9, 2026Break

  IT WAS REPORTED THAT DURING A THERAPEUTIC HYSTERECTOMY PROCEDURE, THE TIP OF THE DEVICE PROBE BROKE OFF BUT DID NOT FALL INTO THE PATIENT. THE PROCEDURE WAS CONVERTED FROM VIDEOLAPAROSCOPY TO OPEN SURGERY; HOWEVER, THIS CHANGE WAS UNRELATED TO THE DEVICE FAILURE. THE CONVERSION WAS NECESSITATED BY THE PATIENT'S CONDITION¿THE UTERUS WAS TOO LARGE AND OCCUPIED THE ENTIRE ABDOMINAL CAVITY. THE PROCEDURE WAS PROLONGED BY APPROXIMATELY 30 MINUTES TO REPLACE THE DAMAGED PROBE WITH ANOTHER DEVICE TO FINISH THE PROCEDURE. NO PATIENT HARM WAS REPORTED IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24297516 ↗
• MalfunctionFeb 9, 2026Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE FRONT-ACTUATED GRIP EXHIBITED THE TISSUE PAD HAD PEELED OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24293966 ↗
• MalfunctionFeb 3, 2026Fracture

  IT WAS REPORTED THE SONICBEAT'S PROBE TIP BROKE DURING A LAPAROSCOPIC ADRENALECTOMY. IT WAS NOT SPECIFIED HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24250922 ↗
• MalfunctionNov 6, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC SURGICAL INSTRUMENT EXHIBITED THE PROBE WAS BROKEN OFF AT 14.11 MILLIMETERS FROM ITS DISTAL END, BROKEN PROBE TIP WAS RETURNED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23486765 ↗
• InjuryMay 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED DURING SEDATION OF A THERAPEUTIC TRANSANAL ENDOSCOPIC OPERATION THE GENERATOR REPORTED AN ERROR A SELF TEST WAS COMPLETED WITH NO EFFECT AND IT WAS SEEN THAT THE JAW OF THE INSTRUMENT HAD FALLEN OFF INSIDE OF THE PATIENT. THERE PROCEDURE WAS NOT PROLONGED AND THERE WERE NO REPORTS OF PATIENT INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21994063 ↗
• MalfunctionApr 25, 2025Degraded; Degraded

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE INSTRUMENT EXHIBITED A WORN, LIFTED UP TEFLON PAD WHICH EXPOSED THE JAW METAL PART DUE TO SEVERE WEAR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21909155 ↗
• MalfunctionMar 21, 2025Material Fragmentation; Material Fragmentation

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21662331 ↗
• MalfunctionMar 7, 2025Peeled/Delaminated; Peeled/Delaminated

  NO ADDITIONAL INFO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21543799 ↗
• MalfunctionMar 7, 2025Degraded; Degraded

  IT WAS REPORTED THE SONICBEAT SURGICAL INSTRUMENT'S SCISSOR PAD STARTED TO WEAR DURING BODY INSERTION WHILE PERFORMING A HEPATO-BILIARY-PANCREATIC PROCEDURE. THE EVENT RESULTED IN A DELAY OF 30 MINUTES OR LESS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER BEING REPLACED WITH A SECOND DEVICE OF THE SAME MODEL. THERE WAS NO REPORT OF DEVICE COMPONENTS FALLING WITHIN PATIENT ANATOMY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21543709 ↗
• MalfunctionJan 15, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE SUBJECT DEVICE HAD A TISSUE PAD THAT PEELED OFF WHEN ENERGIZED FOR NORMAL USE. THE ISSUE OCCURRED DURING A THERAPEUTIC LIVER RESECTION PROCEDURE THAT WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21164492 ↗
• MalfunctionJan 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21068396 ↗
• MalfunctionDec 10, 2024Peeled/Delaminated; Peeled/Delaminated

  NO NEW INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20897250 ↗
• MalfunctionNov 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THERAPEUTIC RAFAELO PROCEDURE THE TISSUE PAD OF THE SUBJECT DEVICE CAME OFF. THE ISSUE WAS FOUND DURING SEDATION AND THE DEVICE WAS INSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER MODEL SONOSURGE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20759092 ↗
• InjuryNov 18, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THERAPEUTIC LAPAROSCOPIC SURGERY, THE PROBE FELL OFF INTO THE PATIENT'S ABDOMINAL CAVITY. IT TOOK LESS THAN 15 MINUTES TO RETRIEVE THE FALLEN PROBE WITH FORCEPS. THE PROCEDURE WAS FINISHED WITH A SIMILAR DEVICE. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20716374 ↗
• InjuryNov 18, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THERAPEUTIC LAPAROSCOPIC SURGERY, THE PROBE FELL OFF INTO THE PATIENT'S ABDOMINAL CAVITY. IT TOOK LESS THAN 15 MINUTES TO RETRIEVE THE FALLEN PROBE WITH FORCEPS. THE PROCEDURE WAS FINISHED WITH A SIMILAR DEVICE. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20714806 ↗
• InjuryNov 15, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THERAPEUTIC MYOMECTOMY, THE TEFLON PAD WAS PARTICULARLY DAMAGED. UPON INSPECTION OF THE INSTRUMENT, A PART OF THE TEFLON PAD WAS MISSING, AND ANOTHER PART WAS SEALED IN THE GROOVE ON THE UPPER SIDE OF THE JAWS. INITIALLY, THE STAFF COULD NOT DETERMINE EXACTLY WHERE THE REMAINING PART OF THE TEFLON WAS LOCATED. THE OPERATING DOCTOR STATED THAT IT WAS PROBABLY SUCTIONED OUT, AND IF IT WAS A PIECE OF TEFLON, IT SHOULD NOT BE AN ISSUE SINCE CLIPS ARE MADE FROM SIMILAR MATERIAL AND REMAIN IN THE BODY. THE VIDEO RECORDING WAS REVIEWED, AND ACCORDING TO THE FOOTAGE, THE INSTRUMENT WAS DAMAGED APPROXIMATELY ON THE THIRD ACTIVATION OF THE DEVICE. APPARENTLY, TWO SMALL PIECES THE SIZE OF PINHEADS FELL OFF, WHICH INITIALLY LOOKED LIKE STEAM DROPLETS. ACCORDING TO THE DOCTOR, THEY WERE LIKELY SUCTIONED OUT DURING THE ABDOMINAL WASH. THE REMAINING DAMAGED PART WAS VISIBLY REMOVED FROM THE ABDOMINAL CAVITY AS PART OF THE INSTRUMENT AND LIKELY FELL OFF DURING THE SUBSEQUENT CLEANING OF THE TOOL, ACCORDING TO THE VIDEO RECORDING. THIS WAS PROBABLY WHY THE TEFLON PAD WAS NOT FOUND AFTERWARD, CAUSING CONCERN. THE PROCEDURE WAS COMPLETED WITHOUT ANY REPORTS OF PATIENT HA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20696529 ↗
• InjuryNov 8, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE PROBE TIP BROKE AND FELL INTO THE PATIENT'S ABDOMINAL CAVITY AND WAS REMOVED IMMEDIATELY BY THE MEDICAL STAFF USING FORCEPS. THIS CREATED A 2 MINUTE DELAY. THE DEVICE WAS INSPECTED PRIOR TO USE AND THERE WAS NO ABNORMALITY NOTED. THE PROCEDURE WAS COMPLETED WITH A BACK UP (SAME) DEVICE WITHOUT DELAY OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20636765 ↗
• MalfunctionOct 29, 2024Material Separation; Material Separation

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THE ULTRASONIC SURGICAL INSTRUMENT EXHIBITED TISSUE PAD PARTIAL SEPARATION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20556259 ↗
• MalfunctionOct 28, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED, THE ULTRASONIC SURGICAL INSTRUMENT TIP OF THE PROBE FELL OFF WHEN IT WAS REMOVED FROM THE PATIENT. IT WAS NOT INSIDE THE BODY, BUT BROKE AND FELL OFF DURING CLEANING. THE ISSUE OCCURRED DURING A THERAPEUTIC LAPAROSCOPIC MYOMA REMOVAL. THERE WERE NO REPORTS OF PATIENT HARM. THE PROCEDURE WAS COMPLETED AFTER CHANGING TO A DIFFERENT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20553473 ↗
• MalfunctionOct 25, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC SURGICAL DEVICE EXHIBITED TISSUE PAD PEELING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20533997 ↗
• MalfunctionOct 23, 2024Break; Break

  IT WAS REPORTED THAT THE PROBE OF THE SONICBEAT BROKE WHEN IT WAS OUTPUTTED 20-30 MINUTES AFTER THE START. THE ISSUE OCCURRED DURING THE THERAPEUTIC CHOLECYSTECTOMY. THE DEVICE DID NOT FALL OFF. 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 20519068 ↗
• MalfunctionOct 23, 2024Break; Break

  IT WAS REPORTED THE SONIBEAT TIP BROKE DURING THE PROBE CHECK. THE ISSUE OCCURRED DURING A THERAPEUTIC THYROIDECTOMY 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 20514317 ↗