NA 530.630Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982240057), received between Sep 30, 2019 and Dec 11, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (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 16, 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.

• MalfunctionDec 11, 2024Battery Problem; Complete Loss of Power; Battery Problem; Complete Loss of Power

  IT WAS REPORTED FROM SPAIN THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY DEVICE WAS SUSPECT ADULTERATED - HOUSING OPEN / SEAL DAMAGED, THE ETCHING WAS WORN, AND THERE WAS USE ERROR/MISUSE -AUTOCLAVING. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR MARKING AND LABELING, GENERAL CONDITION AND LEVER FUNCTION, AND CHECK FOR EXTERNAL CLEANNESS. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED, HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20903132 ↗
• MalfunctionSep 30, 2019Explosion; Explosion

  IT WAS REPORTED FROM (B)(6) THAT THE BATTERY DEVICE EXPLODED. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. IT WAS REPORTED THAT THERE WERE NO ADVERSE PATIENT CONSEQUENCES. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9134815 ↗