NA 0940000000Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327115147), received between Aug 10, 2018 and Jan 28, 2020 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Unintended Power Up” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2020Device Remains Activated; Device Remains Activated

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE HAD RUN-ON. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Patient Involvement

  MAUDE report 9636401 ↗
• MalfunctionOct 28, 2019Device Remains Activated; Device Remains Activated

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE HAD RUN-ON. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Patient Involvement

  MAUDE report 9245095 ↗
• MalfunctionApr 24, 2019Unintended Power Up; Unintended Power Up

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE RAN WITHOUT USER ACTIVATION. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Patient Involvement

  MAUDE report 8545834 ↗
• MalfunctionFeb 8, 2019Unintended Power Up; Unintended Power Up

  IT WAS REPORTED AFTER A PROCEDURE AT THE USER FACILITY THAT THE DEVICE WOULD NOT TURN OFF. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY. NO ADVERSE CONSEQUENCES WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8323288 ↗
• MalfunctionDec 21, 2018Sparking; Sparking

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

  Patient problems: No Patient Involvement

  MAUDE report 8191254 ↗
• MalfunctionOct 29, 2018Unintended Power Up; Unintended Power Up

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE EXPERIENCED A FAIL-SAFE PROBLEM THAT COULD RESULT IN UNINTENDED ACTIVATION. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Patient Involvement

  MAUDE report 8014690 ↗
• MalfunctionAug 10, 2018Unintended Power Up; Unintended Power Up

  IT WAS REPORTED PRIOR TO A PROCEDURE THAT THE DEVICE WOULD TURN ON BY ITSELF.

  Patient problems: No Patient Involvement

  MAUDE report 7773645 ↗