SONICBEAT 5 mm, 45 cm, Front-actuated Grip SB-0545FCRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04953170370571), received between Oct 17, 2018 and Sep 15, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Peeled/Delaminated

  The customer returned the instrument for a separate issue. During the initial evaluation of the returned device, it was observed that the tissue pad was peeled off. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50774323 ↗
• MalfunctionMar 15, 2024Break; Break

  IT WAS REPORTED, THE SONICBEAT'S 5 MM TISSUE PAD CAME OFF. THE ISSUE OCCURRED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18916310 ↗
• MalfunctionAug 30, 2023Material Separation; Material Separation

  A CUSTOMER REPORTED TO OLYMPUS, DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE, AN EVENT OCCURRED WITH THE USE OF 2 SONICBEAT SCISSORS. THE SCISSORS QUICKLY DISPLAYED AN ERROR DURING USE ON THE GENERATOR AT THE START OF THE OPERATION AND WHILE CLEANING WITH A COMPRESS AT THE END, THE PROBE BROKE. THE PROBE BROKE OUTSIDE OF THE PATIENT¿S BODY. THE COATING OF THE THERMOS COAGULATION CLAMP DISINTEGRATED AFTER 3 MINUTES. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT DEVICE. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT. RELATED PATIENT IDENTIFIER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17656615 ↗
• MalfunctionAug 29, 2023Fracture; Fracture

  A CUSTOMER REPORTED TO OLYMPUS, DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE, AN EVENT OCCURRED WITH THE USE OF 2 SONICBEAT SCISSORS. THE SCISSOR QUICKLY DISPLAYED AN ERROR DURING USE ON THE GENERATOR AT THE START OF THE OPERATION AND WHILE CLEANING WITH A COMPRESS AT THE END, THE PROBE BROKE. THE PROBE BROKE OUTSIDE OF THE PATIENT¿S BODY. THE COATING OF THE THERMOS COAGULATION CLAMP DISINTEGRATED AFTER 3 MINUTES. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT DEVICE. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT. RELATED PATIENT IDENTIFIER: (B)(6). USAGE OF SUBJECT DEVICE BEFORE EVENT. THE USG-400 (ULTRASONIC GENERATOR) SOFTWARE VERSION WAS 2.00. THE SETTING OF ITM (INTELLIGENT TISSUE MONITORING) ¿ON¿ WHEN THE SONICBEAT WAS USED. IN THE HOSPITAL, THE SETTING OF ITM IS USUALLY ¿ON¿ WHEN THE SONICBEAT WAS USED. THE USER UNDERSTOOD CHARACTERISTICS OF ITM FUNCTIONALITY. THE USER DID NOT CHANGE THE ITM SETTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17642587 ↗
• MalfunctionMay 22, 2023Insufficient Device Problem Information

  NO REPORT TO THE REPORTER OF MALFUNCTION.

  Patient problems: Insufficient Information

  MAUDE report 16973816 ↗
• MalfunctionMar 27, 2023Overheating of Device; Overheating of Device

  THE CUSTOMER REPORTED THE SONICBEAT FAILED OUT OF THE BOX DURING A THERAPEUTIC SLEEVE GASTRECTOMY PROCEDURE. THE DEVICE TURNED RED HOT ABOUT 2 MM ABOVE THE MIDPOINT (PROXIMAL END, TIP) OF THE TITANIUM PROBE. THE PROBE COOLED DOWN IN A FLEXED UPWARD POSITION AND THE JAWS WERE NO LONGER ABLE TO GRASP. THE PROCEDURE WAS DELAYED ABOUT A MINUTE TO OPEN UP ANOTHER SONICBEAT DEVICE. ANESTHESIA WAS NOT EXTENDED AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. NO MEDICAL INTERVENTION WAS NEEDED. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16617304 ↗
• MalfunctionMar 7, 2023Material Separation; Material Separation

  THE CUSTOMER REPORTED TO OLYMPUS, THE TISSUE PAD OF THE SONICBEAT WAS WORN OUT AND BECAME UNUSABLE DURING A LAPAROSCOPIC HERNIA REMOVAL PROCEDURE. THE PROCEDURE WAS COMPLETED BY REPLACING WITH THE SAME PRODUCT. THERE WAS NO FALLING OFF OF DEBRIS AND NO HEALTH HAZARD. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16498052 ↗
• MalfunctionDec 6, 2022Break; Break

  THE CUSTOMER REPORTED THE PROBE ON THE SUBJECT DEVICE BROKE. ADDITIONAL DETAILS HAVE BEEN REQUESTED REGARDING THE REPORTED EVENT. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THE SUBJECT DEVICE WAS SENT TO OLYMPUS FOR EVALUATION. DURING INSPECTION AND TESTING, THE PROBE WAS FOUND TO BE BROKEN OFF. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION (BROKEN PROBE). THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15928975 ↗
• MalfunctionJul 28, 2022Degraded; Degraded

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, 30 MINUTES INTO A THERAPEUTIC LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE A METALLIC NOISE WAS HEARD AND THE DEVICE TISSUE PAD WAS FOUND TO BE VERY WORN. ERROR MESSAGE RECEIVE IS NOT KNOWN. THE PROCEDURE WAS COMPLETED WITH A NEW SIMILAR DEVICE. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ANOMALY NOTED. THE SETTING AT THE TIME OF THE EVENT WERE MAXIMUM 3/VARIABLE 1. INTELLIGENT TISSUE MONITORING (ITM) FUNCTIONALITY WAS ON DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15125333 ↗
• MalfunctionJun 2, 2022Material Separation; Material Separation

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC) ON BEHALF OF THE CUSTOMER, THE SONICBEAT 5 MM, 45 CM, FRONT-ACTUATED GRIP COULD NOT CONNECT CORRECTLY TO THE CORD DURING A THERAPEUTIC PROCEDURE. SUBSEQUENTLY, THE PROCEDURE WAS COMPLETED. UPON INSPECTION OF THE CUSTOMER¿S RETURNED DEVICE, IT WAS OBSERVED, THE GRASPING PORTION OF THE JAW WAS MISSING. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14583113 ↗
• MalfunctionOct 17, 2018Failure to Fire

  OLYMPUS GRIP DEVICE WOULDN'T FIRE DURING SURGERY.

  Patient problems: No Information

  MAUDE report 7973558 ↗