SONICBEAT 5 mm, 35 cm, Inline Grip SB-0535ICRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04953170308932), received between Mar 24, 2023 and Jun 10, 2024 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE SONICBEAT INLINE GRIP INSTRUMENT EXHIBITED TISSUE PAD DETACHMENT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19503887 ↗
• MalfunctionApr 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TISSUE PAD CAME OFF THE SONICBEAT 5 MM, 35 CM, INLINE GRIP AT ABOUT THIRTY MINUTES OF USE. THE PAD DID NOT FALL INTO THE PATIENT¿S BODY. THE ISSUE OCCURRED DURING A THERAPEUTIC HERNIA SURGERY. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19202496 ↗
• MalfunctionMar 15, 2024Melted; Melted

  IT WAS REPORTED, THE SONICBEAT'S 5 MM'S TISSUE PAD WAS BURNT AND MELTED. THE ISSUE OCCURRED DURING A THERAPEUTIC TRANSABDOMINAL PREPERITONEAL APPROACH. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18918033 ↗
• MalfunctionMay 19, 2023Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER. THE PROBE BROKE OUT OF THE PATIENT'S BODY AND WAS RECOVERED ON THE SPOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16964466 ↗
• MalfunctionMar 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS, DURING A THERAPEUTIC LAPAROSCOPIC HERNIA REPAIR PROCEDURE, THE TISSUE PAD OF THE SONICBEAT 5 MM, 35 CM, INLINE GRIP,CAME OFF. THE CUSTOMER CONFIRMED THAT THE TISSUE PAD DID NOT FALL OFF. SUBSEQUENTLY, THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16609972 ↗