SonoSurg Curved Scissors,HF,Pistol Grip,5mm x 34cmRecalls & reported problems across all models

We found 2 models of SonoSurg Curved Scissors,HF,Pistol Grip,5mm x 34cm by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 57 adverse event reports in the FDA's MAUDE database, received between Oct 5, 2016 and Sep 27, 2024 — classified as 9 injuries, 48 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported SonoSurg Curved Scissors,HF,Pistol Grip,5mm x 34cm problems

SonoSurg Curved Scissors,HF,Pistol Grip,5mm x 34cm models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SonoSurg Curved Scissors,HF,Pistol Grip,5mm x 34cm T3905

  Instrument, ultrasonic surgical
  54 reports
• SonoSurg Curved Scissors,HF,Pistol Grip,5mm x 34cm T3905

  Instrument, ultrasonic surgical
  3 reports

Recent SonoSurg Curved Scissors,HF,Pistol Grip,5mm x 34cm adverse event reports

The 15 most recent reports across all models, 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 ↗

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