SonoSurg Curved Scissors,HF,Inline Grip,5mm x 34cm T3915Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170235689), received between Mar 9, 2023 and Jan 12, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2024Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS THE SONOSURG CURVED SCISSORS HAD EXPOSED METAL AT THE BASE OF THE INSULATION SHEATH. THE ISSUE WAS FOUND DURING AN UNIDENTIFIED PROCEDURE THAT WAS COMPLETED WITH A SIMILAR DEVICE. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THERE WERE SIGNS OF DEVICE ACTIVATION WITHOUT GRASPING TISSUE THAT RESULTED IN THE TISSUE PAD PEELING WHICH CONSTITUTES A REPORTABLE MALFUNCTION. 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 18502760 ↗
• MalfunctionAug 1, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE SONOSURG CURVED SCISSORS HF INLINE GRIP TISSUE PAD WAS DAMAGED (NO SHEDDING). THE ISSUE OCCURRED DURING A THERAPEUTIC PROCEDURE WHICH WAS COMPLETED WITH A SIMILAR DEVICE WITHOUT DELAY. THE SETTING OUTPUT AT THE TIME OF THE EVENT WAS 70%. THERE WERE NO HEALTH HAZARDS OR REPORTS OF PATIENT HARM. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS IDENTIFIED: THE GRIP SURFACE WAS WORN AND PEELING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17437894 ↗
• MalfunctionMar 9, 2023Material Separation; Material Separation

  AS REPORTED FOR THIS EVENT BY THE DISTRIBUTOR, DURING A THERAPEUTIC LAPAROSCOPIC INGUINAL HERNIA REPAIR PART OF THE DEVICE TISSUE PAD FELL OFF. IT WAS CONFIRMED THAT THERE WERE NO FALLEN PIECES INSIDE THE BODY. HOWEVER, THE FALLEN OFF PIECE WAS NOT FOUND, UNTIL A PIECE PRESUMED TO BE THE FALLEN OFF PIECE WAS FOUND OUTSIDE THE PATIENT BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME MODEL NUMBER. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16514552 ↗