SonoSurg Short Hook 5mm O.D. T3080Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04953170152375), received between Nov 29, 2021 and Aug 21, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Break” (4 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.

• InjuryAug 21, 2024Break; Break

  IT WAS REPORTED THAT HIGH-FREQUENCY OUTPUT WAS NOT ACTIVATED ON THE GENERATOR DURING THE TONSILLECTOMY. THE DEVICE USER OBSERVED THAT THE SHEATH FELT HOT AT THE BASE AND ALONG THE BLACK SHEATH. THE MIDDLE OF THE SHEATH WAS IN CONTACT WITH THE LOCATION OF THE PATIENT¿S BURN. THERE WAS LONG CONTACT BETWEEN THE SHEATH AND THE MUCOSA, NEAR THE SECTION OF THE TONSIL (FROM BOTTOM TO TOP). REPORTEDLY, IT IS POSSIBLE THAT THE DEVICE MAY HAVE COME IN CONTACT WITH THE METAL LINGUAL BLADE OF THE RETRACTOR. MOREOVER, THE DEVICE WAS ACTIVATED CONTINUOUSLY FOR AN AVERAGE OF 15 MINUTES PER TEST AND UNTIL THE SAFETY SIGNAL ALARMED. THE OUTPUT LEVEL SETTING WAS PROGRAMMED TO 80%. THE DEVICE WAS ISOLATED AT THE END OF THE PROCEDURE AND NOT REUSED IN A SUBSEQUENT PROCEDURE. THE AGE OF THE PATIENT INVOLVED IN THIS EVENT IS BETWEEN 2-4 YEARS OLD. FINALLY, IT WAS REPORTED THAT SOME INTRODUCER SHEATHS WERE DAMAGED AT THE RING/WHITE SEAL LEVEL.

  Patient problems: Pain; Partial thickness (Second Degree) Burn; Swelling/ Edema

  MAUDE report 20012248 ↗
• InjuryAug 20, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED: IT WAS REPORTED THAT NO HIGH-FREQUENCY OUTPUT WAS ACTIVATED ON THE GENERATORS. THE BASE AND THE BLACK SIDE OF THE SHEATH FELT HOT TO THE USER. THE MIDDLE PORTION OF THE SHEATH WAS IN CONTACT WITH THE PATIENT¿S BURN. PROLONGED CONTACT OCCURRED BETWEEN THE SHEATH AND MUCOSA; A SECTION OF THE TONSIL, FROM BOTTOM TO TOP, CAME INTO CONTACT WITH THE INSIDE OF THE CHEEK. THE SUBJECT DEVICE WAS USED EXCLUSIVELY FOR TONSILLECTOMY PROCEDURES, WITH AN AVERAGE USAGE TIME OF 15 MINUTES PER TEST, UNTIL THE SAFETY SIGNAL WAS TRIGGERED. THE OUTPUT LEVEL SETTINGS WERE AT 80%. THE SUBJECT DEVICE WAS ISOLATED AT THE END OF THE PROCEDURE AND WAS NOT REUSED. THE USER NOTED THAT SOME INTRODUCER SHEATHS APPEARED DAMAGED AT THE RING/WHITE SEAL LEVEL AND QUESTIONED WHETHER THIS COULD BE DUE TO EXCESSIVE STERILIZATION CYCLES OR REPEATED USE. IT WAS ALSO NOTED THAT THE SUBJECT DEVICE MAY HAVE COME INTO CONTACT WITH THE LINGUAL BLADE OF THE RETRACTOR. ADDITIONALLY, IT WAS REPORTED THE AGE CHILDREN RANGE FROM AGES 2-4 YEARS.

  Patient problems: Pain; Partial thickness (Second Degree) Burn; Swelling/ Edema

  MAUDE report 20005974 ↗
• InjuryAug 20, 2024Break; Break

  IT WAS REPORTED DURING A THERAPEUTIC TONSIL PROCEDURE WHILE USING THE ULTRASONIC SURGICAL DEVICE, A CHILD RECEIVED A SECOND-DEGREE MUCOSAL BURN ON THE LIPS AND INNER CHEEKS. THE CUSTOMER STATED THE PROBLEM WAS THOUGHT TO BE HEAT FROM A DAMAGED BLACK SHEATH THAT FITS OVER THE HOOK CAUSING SWOLLEN LIPS AND CHEEK BURNS AFTER THE PROCEDURE. UPON CUSTOMER FOLLOW-UP, IT WAS REPORTED THE PATIENT EXPERIENCED VERY SEVERE PAIN REQUIRING LOCAL TREATMENT, AND THE BURN WAS STILL VISIBLE ON THE LIP WITH ESTHETICAL CONSEQUENCES.

  Patient problems: Pain; Partial thickness (Second Degree) Burn; Swelling/ Edema

  MAUDE report 20003479 ↗
• InjuryAug 20, 2024Break; Break

  IT WAS REPORTED DURING A THERAPEUTIC TONSIL PROCEDURE WHILE USING THE ULTRASONIC SURGICAL DEVICE, A CHILD RECEIVED A SECOND-DEGREE MUCOSAL BURN ON THE LIPS AND INNER CHEEKS. THE CUSTOMER STATED THE PROBLEM WAS THOUGHT TO BE HEAT FROM A DAMAGED BLACK SHEATH THAT FITS OVER THE HOOK CAUSING SWOLLEN LIPS AND CHEEK BURNS AFTER THE PROCEDURE. UPON CUSTOMER FOLLOW-UP, IT WAS REPORTED THE PATIENT EXPERIENCED VERY SEVERE PAIN REQUIRING LOCAL TREATMENT, AND THE BURN WAS STILL VISIBLE ON THE LIP WITH ESTHETICAL CONSEQUENCES.

  Patient problems: Pain; Partial thickness (Second Degree) Burn; Swelling/ Edema

  MAUDE report 20000768 ↗
• InjuryNov 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON NOVEMBER 25, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE LITERATURE "OPTIMAL MANAGEMENT OF PERIPANCREATIC FLUID COLLECTION WITH POSTOPERATIVE PANCREATIC FISTULA AFTER DISTAL PANCREATECTOMY: SIGNIFICANCE OF COMPUTED TOMOGRAPHY VALUES FOR PREDICTING FLUID INFECTION¿. THE PURPOSE OF THE LITERATURE WAS TO EVALUATE THE MANAGEMENT AND OUTCOMES OF PATIENTS WITH POSTOPERATIVE PANCREATIC FISTULA (POPF) AND VERIFY THE SIGNIFICANCE OF COMPUTED TOMOGRAPHY VALUES FOR PREDICTING PERIPANCREATIC FLUID INFECTIONS AFTER DISTAL PANCREATECTOMY. THE OPEN AND LAPAROSCOPIC DISTAL PANCREATECTOMY WAS PERFORMED USING SONOSURG (OLYMPUS) WITH THE HAND-SEWN OR STAPLED CLOSURE TECHNIQUE. THE INCIDENCE AND GRADE OF POPF SEVERITY WERE DETERMINED ACCORDING TO THE 2016 INTERNATIONAL STUDY GROUP FOR PANCREATIC SURGERY (ISGPS) CLASSIFICATION. POSTOPERATIVE COMPLICATIONS WERE EVALUATED USING THE CLAVIEN¿DINDO CLASSIFICATION OF SURGICAL COMPLICATIONS AND STRATIFIED AS GRADES I¿V. IN THE LITERATURE, IT WAS REPORTED 30 CASES OF BIOCHEMICAL LEAKS (BL), 85 CASES OF POPF CLASSIFIED AS GRADE B, 3 CASES OF POPF CLASSIFIED AS GRADE C, AND 1 CASE OF DEATH. ACCORDING TO ISGPS CLASSIFICATION, ¿CONSEQUENTLY, THE FORMER "G

  Patient problems: Fistula

  MAUDE report 12888754 ↗