SonoSurg Curved Scissors,HF,Pistol Grip,5mm x 34cm T3905 (UDI 04953170234972)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170234972), received between Oct 22, 2021 and Sep 23, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS, ON BEHALF OF THE CUSTOMER, THE PROBE BROKE WHILE WIPING DIRT OFF THE SONOSURG CURVED SCISSORS, HF, PISTOL GRIP,5MM X 34CM DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15470775 ↗
• InjuryNov 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE LITERATURE "THE CLINICAL AND BIOLOGICAL IMPACTS OF THE IMPLEMENTATION OF FAST-TRACK PERIOPERATIVE PROGRAMS IN COMPLEX LIVER RESECTIONS: A PROPENSITY SCORE-BASED ANALYSIS BETWEEN THE OPEN AND LAPAROSCOPIC APPROACHES¿. THE PURPOSE OF THE LITERATURE WAS TO EVALUATE THE IMPACT OF THE FAST-TRACK APPROACH IN PATIENTS UNDERGOING COMPLEX LIVER PROCEDURES AND TO ANALYZE FACTORS THAT INFLUENCE MORBIDITY AND FUNCTIONAL RE- COVERY. BETWEEN JANUARY 2004 AND SEPTEMBER 2016, LIVER RESECTIONS WERE PERFORMED AT THE HEPATOBILIARY SURGERY DIVISION OF SAN RAFFAELE HOSPITAL, MILAN, ITALY. THE MINIMALLY INVASIVE LIVER SURGERY (MILS) GROUP (N = 102, STUDY GROUP) AND THE OPEN GROUP (N = 102, CONTROL GROUP) WERE OBTAINED. THE PROCEDURES WERE PERFORMED USING SONOSURG ULTRASONIC DISSECTOR (OLYMPUS) AND THUNDERBEAT (OLYMPUS). IN THE LITERATURE, IT WAS REPORTED EVENTS AS BELOW, BUT THERE WAS NO MORE INFORMATION IN THE LITERATURE. (1) MILS GROUP (NUMBER OF CASES) CONVERSION TO LAPAROTOMY (20) ICU (1) POSTOPERATIVE MORTALITY (2) POSTOPERATIVE MORBIDITY: CLAVIEN-DINDO (CD) I¿II (21), III¿V (11) POSTOPERATIVE LIVER FAILURE (2) ASCITES (6) HEMORRHAGE (2) BILIARY FIS

  Patient problems: Ascites; Cyst(s); Fever; Fistula; Hemorrhage/Blood Loss/Bleeding; Liver Failure; Pleural Effusion

  MAUDE report 12750231 ↗
• InjuryOct 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON MARCH 23, 2020, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE LITERATURE TITLED "LAPAROSCOPIC LEFT LIVER RESECTIONS: HOW FAR CAN WE GO?". THE PURPOSE OF THIS LITERATURE WAS TO EVALUATE POSTOPERATIVE OUTCOMES IN PATIENTS SUBMITTED TO LAPAROSCOPIC ANATOMIC HEPATECTOMIES OF THE LEFT LIVER SEGMENTS RANGING FROM UNISEGMENTECTOMY TO EXTENDED LEFT HEPATECTOMIES, ANALYZING SAFETY AND FEASIBILITY, AND TO COMPARE THE RESULTS AMONG GROUPS OF THESE DIFFERENT PROCEDURES. IN THE LITERATURE, IT WAS REPORTED AS FOLLOWS; FROM OCTOBER 1990 TO MARCH 2016, ALL PATIENTS WHO UNDERWENT A LAPAROSCOPIC ANATOMICAL RESECTION OF THE LEFT LIVER FOR ANY PATHOLOGY AT THE AUTHORS¿ INSTITUTIONS WERE RETROSPECTIVELY IDENTIFIED FROM THREE PROSPECTIVELY MAINTAINED DATABASES. FROM THE THREE CENTERS INVOLVED, 190 PATIENTS WERE SELECTED. ENERGY SOURCES AND PARENCHYMAL DIVISION TECHNIQUES VARIED THROUGHOUT THE STUDY PERIOD AND INCLUDED THE ULTRASONIC DISSECTOR, THE HARMONIC SCALPEL (PRIMARILY SONOSURG (OLYMPUS), AND MORE RECENTLY THE HARMONIC (ETHICON ENDO-SURGERY) OR THE THUNDERBEAT (OLYMPUS). FOLLOWS COMPLICATIONS WERE REPORTED. POSTOPERATIVE MORTALITY (MULTI-ORGAN FAILURE) (1); INTRAOPERATIVE TRANSFUSION (4); C

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Unspecified Hepatic or Biliary Problem; Unspecified Infection

  MAUDE report 12678997 ↗