SONICBEAT 5 mm, 10 cm, Inline Grip SB-0510ICRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170308970), received between Dec 19, 2022 and Nov 9, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 9, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE SONICBEAT 5 MM, 10 CM, INLINE GRIP HAD PART OF THE TISSUE PAD COME OFF. THE EVENT OCCURRED DURING A THERAPEUTIC PROCEDURE. 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 18100502 ↗
• MalfunctionDec 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, WITHIN 30 MINUTES DURING A THERAPEUTIC THYROIDECTOMY PROCEDURE THE DEVICE TISSUE PAD DETACHED. ANOTHER DEVICE WAS USED PRIOR TO THIS ONE. THAT DEVICE HAD THE TISSUE PAD DETACHED AS WELL. THERE WERE NO ERROR MESSAGES RECEIVED FOR THE ISSUES. THE DETACHING OF THE TISSUE PADS WAS OBSERVED VISUALLY. THE PROCEDURE WAS COMPLETED WITH A THIRD DEVICE FROM THE SAME LOT WITH NO DELAY. PATIENT DID NOT NEED ADDITIONAL ANESTHESIA. TOTAL PROCEDURE TIME WAS LESS THAN TWO HOURS. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT. THE FUNCTIONAL MODE AND SETTINGS AT THE TIME OF THE EVENT WAS SEAL AND CUT 1, LEVEL 3. DEVICE WAS INSPECTED PRIOR TO USE WITH NO ABNORMALITY NOTED. THE INTELLIGENT TISSUE MONITORING (ITM) SETTING WAS ON DURING THE PROCEDURE. THE CONNECTIONS TO THE GENERATOR WERE CHECKED. THE CORDS OF TRANSDUCER AND OTHER MEDICAL DEVICE CORDS WERE NOT BUNDLED TOGETHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16004324 ↗
• MalfunctionDec 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, FIFTEEN MINUTES INTO A THERAPEUTIC THYROIDECTOMY PROCEDURE THE DEVICE TISSUE PAD DETACHED. THE OPERATOR CONTINUED THE PROCEDURE WITH ANOTHER DEVICE FROM THE SAME LOT. HOWEVER, THE TISSUE PAD OF THE SECOND DEVICE DETACHED UPON STARTING AS WELL. THERE WERE NO ERROR MESSAGES RECEIVED FOR THE ISSUES. THE DETACHING OF THE TISSUE PADS WAS OBSERVED VISUALLY. THE PROCEDURE WAS COMPLETED WITH A THIRD DEVICE FROM THE SAME LOT WITH NO DELAY. PATIENT DID NOT NEED ADDITIONAL ANESTHESIA. TOTAL PROCEDURE TIME WAS LESS THAN TWO HOURS. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT. THE FUNCTIONAL MODE AND SETTINGS AT THE TIME OF THE EVENT WAS SEAL AND CUT 1, LEVEL 3. DEVICE WAS INSPECTED PRIOR TO USE WITH NO ABNORMALITY NOTED. THE INTELLIGENT TISSUE MONITORING (ITM) SETTING WAS ON DURING THE PROCEDURE. THE CONNECTIONS TO THE GENERATOR WERE CHECKED. THE CORDS OF TRANSDUCER AND OTHER MEDICAL DEVICE CORDS WERE NOT BUNDLED TOGETHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16004285 ↗