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InterPulse 0210112000ERecalls & reported problems

Stryker Corporation · Handpiece Set with Soft Tissue Tip and Suction Tube · Class 2

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 04546540861696), received between Dec 12, 2016 and Dec 12, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (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

  • Leak/Splash1

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 12, 2016Leak/Splash; Leak/Splash

    THE CUSTOMER REPORTED THAT AN ACETABULAR RECONSTRUCTION WAS BEING PERFORMED. THE SCRUB TECH AT THE USER FACILITY CUT THE TUBING OF THE DEVICE, ¿IN ORDER TO RUN SALINE INTO THE TUBING FROM A STERILE BOWL¿ TO USE A AQUEOUS CHLORHEXIDINE WASH. THE SCRUB NURSE DEPRESSED THE TRIGGER AND A DARK FLUID LEAKED FROM THE HANDPIECE. THE DEVICE WAS NOT USED IN THE STERILE FIELD. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT DEVICE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6167649 ↗

Other LAVAGE, JET devices

All LAVAGE, JET devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.