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Olympus A70951ARecalls & reported problems

OLYMPUS Winter & Ibe GmbH · Trocar tube "High-Flow", 4 mm, 2 stopcocks, rotatable · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
14
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04042761010573), received between Jun 14, 2023 and Mar 30, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (7 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 16, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 1 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 0 reportsMay 2025: 1 reportsJun 2025: 0 reportsJul 2025: 1 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 2 reportsMar 2026: 6 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520266
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Material Deformation7
  • Break6
  • Deformation Due to Compressive Stress1
  • Fracture1
  • Material Twisted/Bent1
  • Sharp Edges1

Patient problems

  • No Clinical Signs, Symptoms or Conditions14

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 30, 2026Material Deformation

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE TROCAR TUBE EXHIBITED A DEFORMED DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24723023 ↗
  • MalfunctionMar 20, 2026Material Deformation

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE TROCAR TUBE HAD A DEFORMED DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24654631 ↗
  • MalfunctionMar 20, 2026Material Deformation

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE TROCAR TUBE HAD A DEFORMED DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24654056 ↗
  • MalfunctionMar 14, 2026Break

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE TROCAR TUBE EXHIBITED A BROKEN INSERTION PIPE. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24599780 ↗
  • MalfunctionMar 9, 2026Material Twisted/Bent

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE TROCAR TUBE WAS SLANTED WITH A SPIKE STUCK IN IT. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24552511 ↗
  • MalfunctionMar 6, 2026Material Deformation

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE DISTAL END ON THE INSERTION TUBE OF THE TROCAR TUBE WAS DEFORMED. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24530818 ↗
  • MalfunctionFeb 3, 2026Break

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE TROCAR TUBE HAD A BROKEN INSERTION PIPE. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24251435 ↗
  • MalfunctionFeb 3, 2026Break; Fracture

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE TROCAR TUBE HAD A SHAVED AND CRACKED INSERTION PIPE. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24251402 ↗
  • MalfunctionJul 17, 2025Break; Deformation Due to Compressive Stress; Sharp Edges; Break; Deformation Due to Compressive Stress; Sharp Edges

    IT WAS REPORTED THE SUBJECT DEVICE HAD A DISTORTED DISTAL END WITH SHARP EDGES AND A DAMAGED TAP SECTION. THERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22528165 ↗
  • MalfunctionMay 5, 2025Material Deformation; Material Deformation

    IT WAS REPORTED THAT THE SUBJECT DEVICE HAD SLIGHTLY DEFORMED DISTAL END OF TUBE. THE ISSUE OCCURRED DURING INSPECTION OF THE DEVICE FOR USE BEFORE PATIENT IN A ROOM. THERE WERE NO REPORTS OF PATIENT HARM

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21962200 ↗
  • MalfunctionMar 19, 2025Material Deformation; Material Deformation

    IT WAS REPORTED THAT THE DISTAL END WAS BENT. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21644461 ↗
  • MalfunctionMar 28, 2024Break; Break

    IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE ARTHROSCOPY SYSTEM EXHIBITED THE TIP OF THE TUBE WAS BROKEN. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18993343 ↗
  • MalfunctionJul 24, 2023Break; Break

    THE CUSTOMER REPORTED TO OLYMPUS. THE DISTAL END OF THE TROCAR BROKE OFF. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM. THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17386022 ↗
  • MalfunctionJun 14, 2023Material Deformation; Material Deformation

    THE CUSTOMER REPORTED THAT THE HIGH-FLOW TROCAR TUBE HAS ¿DEFORMATION OF THE TIP.¿ IT WAS NOT SPECIFIED WHEN THE EVENT WAS FOUND, HOWEVER, THE INTENDED PROCEDURE WAS COMPLETED. NO DEATH OR INJURY AND NO IMPACT TO PATIENT OR OTHER HAS BEEN REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17132113 ↗

Other Arthroscope devices

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Sources and updates

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