KINCISE 2000-01-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07612334268570), received between Apr 14, 2026 and Apr 14, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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. 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.

• MalfunctionApr 14, 2026Leak/Splash

  THIS IS REPORT 2 OF 2 OF (B)(4) IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT WHEN SURGEON TURNED THE KINCISE RECHARGEABLE LI-ION BATTERY DEVICE UP TO USE, IT STARTED TO ¿LEAK¿ WHAT LOOKED LIKE WATER OUT OF IT WHERE THE BATTERY DEVICE AND KINCISE ATTACHMENT DEVICE TOGETHER. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24876312 ↗
• MalfunctionApr 14, 2026Leak/Splash

  THIS IS REPORT 1 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT WHEN SURGEON TURNED THE KINCISE RECHARGEABLE LI-ION BATTERY DEVICE UP TO USE, IT STARTED TO ¿LEAK¿ WHAT LOOKED LIKE WATER OUT OF IT WHERE THE BATTERY DEVICE AND KINCISE ATTACHMENT DEVICE TOGETHER. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24876311 ↗