SonoSurg Curved Scissors,HF,Pistol Grip,5mm x 34cm T3905 (UDI 04953170235665)Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 04953170235665), received between Oct 5, 2016 and Sep 27, 2024 — classified as 7 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Break” (26 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 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2024Break; Break

  IT WAS REPORTED, THE CURVED SCISSORS EXHIBITED A BROKEN OFF PROBE (NO FALL OUT IN THE BODY). THE ISSUE OCCURRED DURING A PROCEDURE FOR AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF DELAY, PATIENT HARM, INJURY, OR DEATH. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20328148 ↗
• InjuryAug 27, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SUBJECT DEVICE FELL INTO THE ABDOMINAL CAVITY AND THE SIZE OF THE PIECE IS 1CM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20078576 ↗
• MalfunctionJun 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE SONOSURG SCISSORS EXHIBITED A BROKEN PROBE 15.5MM FROM THE TIP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19620738 ↗
• MalfunctionJun 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE CURVED SCISSORS EXHIBITED PAD DETACHMENT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19582208 ↗
• MalfunctionJun 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PROBE DETACHED FROM THE PISTOL GRIP DURING A THERAPEUTIC PROCEDURE. THE DEVICE WAS REPLACED WITH A SIMILAR ONE, ALLOWING THE PROCEDURE TO BE SUCCESSFULLY COMPLETED WITHOUT ANY REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19571081 ↗
• MalfunctionMay 24, 2024Break; Break

  IT WAS REPORTED DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE SCISSORS WAS REMOVED AND WIPED OFF WITH GAUZE BEFORE THE PROCEDURE, THE PROBE BROKE OFF OUTSIDE THE BODY. THERE WERE NO REPORTS OF IT FALLING OFF INSIDE THE BODY. 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 19397443 ↗
• MalfunctionApr 15, 2024Pitted; Pitted

  IT WAS REPORTED, THE SONOSURG CURVED SCISSORS,HF,PISTOL GRIP,5MM X 34CM EXHIBITED THAT THE TIP OF THE PROBE WAS CHIPPED. THE ISSUE OCCURRED DURING A THERAPEUTIC LAPAROSCOPIC INGUINAL HERNIA REPAIR PROCEDURE. 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 19112199 ↗
• InjuryFeb 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "MO36-1 A CASE OF SINGLE HOLE LAPAROSCOPIC WINDOW OPENING FOR GIANT HEPATIC CYST WITH INTRAOPERATIVE PREVENTION OF BILE LEAK BY COMBINED USE OF ICG FLUORESCENCE."     ¿LITERATURE SUMMARY¿ THE PATIENT IS AN 84-YEAR-OLD MAN. HE WAS REFERRED TO OUR DEPARTMENT AFTER AN ABDOMINAL CT SCAN REVEALED AN 18.7 CM DIAMETER LIVER CYST IN THE S2 OF THE LIVER. ON PHYSICAL EXAMINATION AT THE TIME OF ADMISSION, A HUGE ABDOMINAL BULGE WITH MOBILITY WAS SEEN IN THE LEFT UPPER ABDOMEN. THE DIAGNOSIS OF A SYMPTOMATIC GIANT SIMPLE HEPATIC CYST WAS MADE, AND A SINGLE HOLE LAPAROSCOPIC WINDOW OPENING WAS PERFORMED. THE LAPAROSCOPE WAS AN OLYMPUS VISERA ELITE II WITH IR MODE AFTER INTRAVENOUS ICG. FIRST, THE LIVER CYST WAS PUNCTURED WITH A SAND BALLOON, AND AFTER ASPIRATING THE FLUID (1900 ML), THE CYST WALL WITH POOR FLUORESCENCE WAS DISSECTED WITH SONOSURG WHILE USING IR MODE. AFTER CAUTERIZING THE CYST WALL, THE CYST WALL WAS OBSERVED AGAIN WITH IR MODE, AND A SMALL AMOUNT OF ICG WAS FOUND LEAKING FROM THE DISSECTED EDGE OF THE CYST WALL. WE CONSIDERED IT TO BE A BILE SCAR AND CLIPPED THE SAME AREA, AFTER WHICH THE SURGERY WAS COMPLETED.

  Patient problems: Fistula; Pneumonia

  MAUDE report 18646226 ↗
• MalfunctionJan 22, 2024Melted; Excessive Heating; Melted; Excessive Heating

  THE CUSTOMER REPORTED TO OLYMPUS THAT WHEN USING THE SONOSURG CURVED SCISSORS FOR THE FIRST TIME, THE TIP OF THE PAD BURNED AND MELTED AFTER SEVERAL OUTPUTS. NO INTERNAL SHEDDING OCCURRED. THE THERAPEUTIC PROCEDURE WAS COMPLETED WHILE USING A REPLACEMENT DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18553579 ↗
• MalfunctionJan 10, 2024Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT WHEN USING THE SONOSURG CURVED SCISSORS, HF, PISTO, THE PROBE BROKE AND FELL OUTSIDE OF THE PATIENT'S BODY CAVITY. THE BROKEN PARTS WERE COLLECTED. THERE WERE NO DELAY WITH THE PROCEDURE. THE ISSUE OCCURRED DURING PROCEDURE, AND THE THERAPEUTIC LAPAROSCOPIC CHOLECYSTECTOMY WAS COMPLETED BUT WAS UNSPECIFIED IF IT WAS COMPLETED WITH THE SAME SET OF EQUIPMENT OR SIMILAR. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18483972 ↗
• MalfunctionDec 20, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THAT THE TIP OF THE PROBE BROKE WHILE USING THE SONOSURG CURVED SCISSORS. SHORTLY AFTER THE POWER WAS TURNED ON, THE CUSTOMER STATED THAT THERE WERE NO FORCE BEING APPLIED TO THE TIP. NO BURNT MARKS OR INTERNAL SHEDDING WERE FOUND. THE ISSUE OCCURRED DURING THE THERAPEUTIC PROCEDURE, AND IT WAS COMPLETED BY SWITCHING TO A SIMILAR DEVICE, WITH A DELAY IN WHICH THE TIMEFRAME WAS NOT SPECIFIED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18367115 ↗
• MalfunctionDec 4, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS, THE SONOSURG CURVED SCISSORS EXPERIENCED AN OUTPUT PROBLEM, AND THE TISSUE PAD WAS WORN OUT. THE ISSUE WAS FOUND DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. 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 18254189 ↗
• MalfunctionNov 28, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THAT THE ULTRASONIC SURGICAL DEVICE PROBE TIP BROKE. THE ISSUE WAS FOUND DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18219905 ↗
• MalfunctionNov 17, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE SONOSURG CURVED SCISSORS,HF,PISTOL GRIP,5MM X 34CM HAD THE WHITE PAD ON THE SIDE PARTIALLY PEEL OFF. THE ISSUE WAS FOUND DURING THE THERAPEUTIC LAPAROSCOPIC APPENDECTOMY PROCEDURE WHICH WAS COMPLETED WITH A SIMILAR DEVICE. THE DEVICE WAS RETURNED FOR EVALUATION AND DURING THE EVALUATION THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: ONE OF THE PINS THAT SERVES AS THE FULCRUM OF THE GRIP PART IS BROKEN. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18160300 ↗
• MalfunctionOct 31, 2023Peeled/Delaminated; Peeled/Delaminated

  THE ULTRASONIC SURGICAL DEVICE WAS SENT TO AN OLYMPUS SERVICE CENTER FOR EVALUATION WITH A REPORT THAT THERE WAS BLACK RUBBER MATERIAL THAT CAME OUT FROM INSIDE THE HANDLE WHILE CLEANING. THE CUSTOMER ALSO NOTED THAT THEY WERE NOT ABLE TO COLLECT THE RUBBER PARTS, SO THEY WOULD LIKE TO CONFIRM THAT THERE ARE NO MISSING PARTS INSIDE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT. DURING INSPECTION, IT WAS FOUND THAT SOME OF THE INTERNAL SILICONE RUBBER HAD PEELED OFF, AND THE GRIPPING SURFACE HAD PEELED OFF. THE MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18039005 ↗
• MalfunctionOct 2, 2023Material Separation; Material Separation

  AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF A CUSTOMER, AFTER USING SONOSURG CURVED SCISSORS FOR 2 TO 3 CASES, THE TISSUE PAD BEGAN TO MELT DURING SURGERY AND COULD NO LONGER BE USED. THERE WAS NO SHEDDING WITHIN THE PATIENT¿S BODY. THE UNSPECIFIED THERAPEUTIC PROCEDURE WAS COMPLETED USING A REPLACEMENT DEVICE (SAME MODEL NUMBER). THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17856419 ↗
• MalfunctionSep 26, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED THAT THE BLACK PART OF THE INSERTION PART OF THE SUBJECT DEVICE CAME OFF AND THE STAINLESS-STEEL PIPE INSIDE WAS EXPOSED. THE REPORTED ISSUE WAS OBSERVED DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING ANOTHER DEVICE WITHOUT A DELAY. REPORTEDLY, THE PEELED PART WAS THE INSULATING PART ON THE OUTSIDE OF THE INSERTION PART AND THERE WAS NO DROPOUT INTO THE PATIENT¿S BODY. THERE WAS NO REPORT OF PATIENT OR USER INJURY DUE TO THE EVENT. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. UPON INSPECTION AND TESTING OF THE DEVICE, IT WAS OBSERVED THAT THE GRIPPING SURFACE WAS PEELING OFF. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING DEVICE EVALUATION (PEELING OF GRIPPING SURFACE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17821306 ↗
• MalfunctionSep 18, 2023Material Separation; Material Separation

  IT WAS REPORTED TO OLYMPUS, THAT THE SONOSURG CURVED SCISSORS TISSUE PAD PART HAD A WORN OUT TIP AND WAS UNUABLE. THE ISSUE WAS FOUND DURING A THERAPEUTIC PROCEDURE AND IT WAS COMPLTED WITH A SIMILAR DEVICE. IT WAS NOTED THAT THE DEVICE WAS USED FOR THE SECOND TIME. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17769776 ↗
• MalfunctionSep 18, 2023Peeled/Delaminated; Peeled/Delaminated

  THE OLYMPUS REPRESENTATIVE (ON BEHALF OF THE CUSTOMER) REPORTED TO OLYMPUS, THE SONOSURG CURVED SCISSORS, HF, PISTOL GRIP, 5MM X 34CM WAS USED FOR THE SECOND TIME AFTER DELIVERY, THE ULTRASOUND OUTPUT ABNORMALITY LIGHT CAME ON WHEN OUTPUTTING ULTRASOUND, AND IT STOPPED WORKING. THE ISSUE WAS FOUND DURING AN UNSPECIFIED PROCEDURE, WHICH WAS COMPLETED WITH A SIMILAR DEVICE. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: THE GRIPPING SURFACE WAS WORN AND PARTIALLY PEELED OFF. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17765972 ↗
• MalfunctionSep 15, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS, WHEN CHECKING THE INSULATION OF THE SONOSURG CURVED SCISSORS, HF, PISTOL GRIP, 5MM X 34CM IT WAS FOUND THAT AN INSULATION FAILURE OCCURRED. THE SHEATH INSULATION PART WAS DAMAGED. THE ISSUE WAS FOUND DURING PREPARATION FOR USE. INSPECTION AND TESTING OF THE RETURNED DEVICE FOUND PEELING OF THE GRIPPING SURFACE. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17761544 ↗
• MalfunctionSep 12, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE SONOSURG CURVED SCISSORS,HF,PISTOL GRIP,5MM X 34CM HAD AN ERROR OCCUR AND WOULD NOT OUTPUT. THE EVENT OCCURRED DURING A THERAPEUTIC PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. THE DEVICE WAS EVALUATED, AND IT WAS FOUND THAT THE SURFACE OF THE GRASPING SECTION WAS PARTIALLY PEELED OFF. THIS MDR (MEDICAL DEVICE REPORT) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17729548 ↗
• InjuryJul 20, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS THE SONOSURG CURVED SCISSORS, HIGH FREQUENCY, WITH PISTOL GRIP WAS NOT ABLE TO SEAL A BLOOD VESSEL WHEN OUTPUT WAS ACTIVATED. THE ISSUE OCCURRED DURING A LAPAROSCOPIC APPENDECTOMY. DURING THE SAME PROCEDURE, HEMOSTASIS WAS ACHIEVED USING BIPOLAR ENERGY WITH NO BLOOD TRANSFUSION BEING NECESSARY. AFTER HEMOSTASIS WAS ACHIEVED, THE ADIPOSE TISSUE WAS SEALED SUCCESSFULLY. INSPECTION AND TESTING OF THE RETURNED DEVICE FOUND THE DEVICE OUTPUT WAS ACTIVATED WITHOUT THE PRESENCE OF TISSUE BETWEEN THE PROBE AND TEFLON PAD WHICH IS KNOWN TO DAMAGE THE DEVICE. THERE WERE NO REPORTS OF ADDITIONAL PATIENT IMPACT DUE TO THE DEVICE MALFUNCTION. RELATED PATIENT IDENTIFIERS: (B)(4)SONOSURG CURVED SCISSORS, HIGH FREQUENCY, WITH PISTOL GRIP. (B)(4) SONOSURG TRANSDUCER. (B)(4) ULTRASONIC SURGICAL SYSTEM SONOSURG. THIS REPORT IS FOR (B)(4).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17367011 ↗
• MalfunctionJul 18, 2023Fracture; Fracture

  AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF A CUSTOMER, THE SONOSURG CURVED SCISSORS OUTPUT COULD NOT BE GENERATED IN THE ABDOMINAL CAVITY DURING A THERAPEUTIC GASTROINTESTINAL SURGERY. THE PROBE WAS DAMAGED WHEN THE OUTPUT WAS OUTSIDE THE BODY CAVITY. THE DAMAGE TO THE PROBE WAS IT HAD FALLEN OFF. NO ERROR OCCURRED DURING THE EVENT. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT PROBE AND SCISSORS. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17346334 ↗
• MalfunctionJun 5, 2023Peeled/Delaminated; Material Separation; Peeled/Delaminated; Material Separation

  THE CUSTOMER REPORTED TO OLYMPUS AFTER THE SECOND AND THIRD CASES USING SONOSURG CURVED SCISSORS, HF, PISTOL GRIP,5MM X 34CM, THE TISSUE PAD PART TURNED UP DURING A THERAPEUTIC LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE SAME EQUIPMENT. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17064365 ↗
• InjuryMay 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE AUTHOR CONFIRMED THERE WERE NO OLYMPUS DEVICE MALFUNCTION DURING ANY PROCEDURE DESCRIBED IN THIS LITERATURE AND THE AUTHOR DOESN'T THINK OLYMPUS DEVICE CAUSE OR CONTRIBUTE TO ANY OF THE PATIENT ADVERSE EVENTS (INCLUDE DEATH) DESCRIBED IN THIS LITERATURE.

  Patient problems: Pancreatitis; Pneumonia; Post Operative Wound Infection

  MAUDE report 16950930 ↗