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
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 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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