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NA 0210058000Recalls & reported problems

Stryker Corporation · SIPS Multiple-Orifice Coaxial Tip · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540861504), received between Dec 2, 2019 and Dec 2, 2019 — classified as 1 malfunction.

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.

Most reported problems

Device problems

  • Break1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 2, 2019Break; Break

    IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY, THE GASKET ON THE IRRIGATOR TIP WAS BROKEN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; THERE WERE NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9396579 ↗

Other LAVAGE, JET devices

All LAVAGE, JET devices →

Sources and updates

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