NA 0502880324Recalls & reported problems
Stryker Corporation · 24 Fr. Standard Flow Resectoscope Sheath · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327063486), received between Nov 22, 2024 and Nov 22, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Fracture1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 22, 2024Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE PLASTIC TIP BROKE OFF WHILE INSIDE THE PATIENT. IT WAS REPORTED THAT THEY WERE ABLE TO GET MOST OR POSSIBLY ALL OF THE PIECES OF THE PATIENT, HOWEVER THEY WOULD LIKE TO CONFIRM VIA XRAY.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 20762104 ↗
Other EVACUATOR, GASTRO-UROLOGY devices
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- Gyrus ACMI 194-2Gyrus ACMI, LLC · EVACUATOR, GASTRO-UROLOGY1 recall0 reports
- Toomey 188Gyrus ACMI, LLC · EVACUATOR, GASTRO-UROLOGY1 recall0 reports
- USA Elite 191-NRSGyrus ACMI, LLC · EVACUATOR, GASTRO-UROLOGY1 recall0 reports
- Toomey 188AGyrus ACMI, LLC · EVACUATOR, GASTRO-UROLOGY1 recall0 reports
- Gyrus ACMI 190-4Gyrus ACMI, LLC · EVACUATOR, GASTRO-UROLOGY1 recall0 reports
- Bard® Ellik Evacuator 000451C. R. Bard, Inc. · EVACUATOR, GASTRO-UROLOGY42 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.