KINCISE™ 1002-00-102Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00845384018537), received between Jan 7, 2022 and Mar 9, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2026Leak/Splash

  IT WAS REPORTED THAT DURING CLEANING, IT WAS OBSERVED THAT THE KINCISE RECHARGEABLE LI-ION BATTERY DEVICE - THE BATTERY WAS LEAKING BATTERY FLUID. THE EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24546153 ↗
• MalfunctionOct 25, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE KINCISE DEVICE WAS BROKEN. 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 THE SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. 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 20532068 ↗
• MalfunctionJul 26, 2024Corroded; Electrical /Electronic Property Problem; Corroded; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT AFTER A SURGICAL PROCEDURE THE KINCISE DEVICE HAD CORROSION BUILD-UP IN ONE OF THE CHARGING BLADES OF THE BATTERY PACK THAT CAUSED IT TO SHORT OUT. THE CYCLE COUNT IS 010. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. 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 WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19839449 ↗
• MalfunctionJan 7, 2022Electrical /Electronic Property Problem; Appropriate Device Problem Term/Code Not Available; Electrical /Electronic Property Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, WHILE USING THE IMPACTOR DEVICE IT WAS DISCOVERED THAT THE BATTERY DEVICE WAS NOT FUNCTIONING PROPERLY. IT WAS SHORTING OUT WHILE PULLING THE TRIGGER. IT WAS FURTHER REPORTED THAT WHILE EXTRACTING THE FEMORAL HEAD, THE T-HANDLE DEVICE CRACKED ON THE WHITE HANDLE WHERE THE SURGEON GRABS ONTO. ACCORDING TO THE REPORTER, THE SURGEON WAS USING A MALLET ON THE T-HANDLE AND THE WHITE PART CRACKED. IT WAS REPORTED THAT NOTHING BROKE OFF FROM THE INSTRUMENT. IT WAS REPORTED THAT THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 13190832 ↗