GLOBAL ADVANTAGE 2128-01-021Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295088035), received between Aug 7, 2018 and Apr 15, 2024 — classified as 2 malfunctions.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionApr 15, 2024Break; Failure to Cut; Break; Failure to Cut

  THIS INSTRUMENT IS COMPOSED OF 1 PART. THE TIP OF THE INSTRUMENT IS CHIPPED AND DULL. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19112449 ↗
• MalfunctionAug 7, 2018Naturally Worn; Naturally Worn

  THESE INSTRUMENTS ARE WORN OUT AND NEEDS TO BE CHANGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7757999 ↗