Saber 5100120480S1Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613154610518), received between Apr 1, 2019 and Apr 14, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (6 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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2021Overheating of Device; Overheating of Device

  THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE DEVICE OVERHEATED WHILE IT WAS BEING DEMONSTRATED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11665999 ↗
• MalfunctionApr 14, 2021Overheating of Device; Overheating of Device

  THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE DEVICE OVERHEATED WHILE IT WAS BEING DEMONSTRATED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11665985 ↗
• MalfunctionJun 17, 2019Overheating of Device; Overheating of Device

  IT WAS REPORTED THE DEVICE HAD HEAT DURING TESTING CONDUCTED BY A MANUFACTURER FIELD SERVICE TECHNICIAN AT THE USER FACILITY. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8703827 ↗
• MalfunctionApr 3, 2019Overheating of Device; Overheating of Device

  IT WAS REPORTED THE DEVICE OVERHEATED DURING TESTING AT THE USER FACILITY. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8478729 ↗
• MalfunctionApr 3, 2019Overheating of Device; Overheating of Device

  IT WAS REPORTED THE DEVICE OVERHEATED DURING TESTING CONDUCTED AT THE USER FACILITY. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8478726 ↗
• MalfunctionApr 1, 2019Overheating of Device; Overheating of Device

  IT WAS REPORTED THE DEVICE OVERHEATED DURING TESTING CONDUCTED AT THE USER FACILITY. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8470319 ↗