Tools - HPS GAUGE-1.6/2.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842188111815), received between Jan 26, 2018 and Jan 26, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Operational Issue” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2018Device Operational Issue; Device Operational Issue

  THE INDIVIDUAL UTILIZING THE GAUGE-1.6/2.0 WAS HAVING REASSEMBLY ISSUES POST CLEANING AND AUTOCLAVE PROCESS. IN ADDITION TO THIS COMPLAINT, IT WAS DIFFICULT FOR THE SURGEON TO FEEL THE FAR CORTEX WITH THE HOOK OF THE GAUGE ACCORDING TO THE SALES REPRESENTATIVE INVOLVED IN THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7223515 ↗
• MalfunctionJan 26, 2018Device Operational Issue; Device Operational Issue

  THE PROCESSING PERSONNEL IN THE FACILITY WAS HAVING REASSEMBLY ISSUES WITH THE GAUGE-1.6/2.0. THE INDIVIDUAL RESPONSIBLE FOR PREPARING THE TOOLS FOR CLEANING AND AUTOCLAVE PROCESS WAS UNCERTAIN ON HOW TO REASSEMBLE THE PARTS DUE TO DESIGN COMPLEXITY AND SIMILARITY WITH ANOTHER GAUGE FOUND IN THE TRAY. IN ADDITION TO THIS COMPLAINT, IT WAS NOT INTUITIVELY APPARENT ON HOW TO UTILIZED THE TOOL ACCORDING TO THE SALES REPRESENTATIVE INVOLVED IN THE CASE. THE SURGEON WAS NOT ABLE TO PROPERLY IDENTIFY WHICH MARKING TO USE DURING THE SURGERY. THUS, CAUSING TO MISUSE THREE SCREWS PRIOR TO USING COMPETITORS TOOL TO COMPLETE THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7223502 ↗