KINCISE 2000-00-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 07612334268563), received between Jan 29, 2025 and Sep 15, 2026 — classified as 33 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (14 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50779197 ↗
• MalfunctionSep 15, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50771706 ↗
• MalfunctionAug 25, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50433672 ↗
• MalfunctionAug 25, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50430610 ↗
• MalfunctionMay 14, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING PRE-SURGERY TESTING IT WAS OBSERVED THAT ALL THREE BUTTONS ON THE IMPACTOR DEVICE WERE STUCK. IT WAS REPORTED THAT THEY WERE ALL STUCK HALFWAY DOWN AND COULD NOT BE PRESSED BY THE SCRUB TECH. IT WAS REPORTED THAT A SPARE DEVICE WAS AVAILABLE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. 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 2026. 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 25176573 ↗
• MalfunctionApr 21, 2026Unintended System Motion

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT WHEN USING THE FORWARD TRIGGER OF THE IMPACTOR DEVICE AND HOLDING IT DOWN, AND WHEN RELEASING THE FORWARD TRIGGER, THE HAND UNIT WOULD FIRE BY ITSELF IN REVERSE FOR A CLICK OR TWO. IT WAS REPORTED THAT THE REVERSE TRIGGER WAS NOT PRESSED. 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 24938857 ↗
• MalfunctionApr 14, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TOP REVERSE BUTTON ON THE KINCISE¿ SURGICAL AUTOMATED SYSTEM DEVICE FELL OFF. THE ISSUE WAS OBSERVED PRE-SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE ISSUE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24874590 ↗
• MalfunctionApr 11, 2026Leak/Splash

  IT WAS REPORTED THAT WHEN THE SURGEON TURNED ON THE KINCISE HANDPIECE DEVICE TO USE IT, FLUID THAT APPEARED TO BE WATER LEAKED FROM THE BATTERY¿HANDPIECE CONNECTION. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. 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 24847115 ↗
• MalfunctionMar 13, 2026Unintended System Motion

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE IMPACTOR DEVICE FIRED ON ITS OWN WITHOUT HITTING ANY BUTTONS. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR WHETHER A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24590173 ↗
• MalfunctionFeb 2, 2026Electrical /Electronic Property Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE IT WAS OBSERVED THAT THE KINCISE SURGICAL AUTOMATED SYSTEM DEVICE WOULD ACTIVATE AND IMPACT NINE TO TEN TIMES WITH ONE TRIGGER PULL. THE TRIGGER SEEMS TO GET STUCK. THERE WAS NO REPORT OF A DELAY IN THE PROCEDURE. 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 24233612 ↗
• MalfunctionJan 22, 2026Unintended System Motion

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE BATTERY HANDPIECE DEVICE WOULD NOT STOP FIRING AFTER FINGER OFF THE TRIGGER. 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 24146090 ↗
• MalfunctionDec 26, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE HANDPIECE DEVICE ACTIVATED WHEN ITS TRIGGER WAS PRESSED BUT DID NOT STOP WHEN THE TRIGGER WAS RELEASED. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. 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 23895676 ↗
• MalfunctionNov 10, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE MOTOR DEVICE K2 GUN THAT HAS BEEN MISFIRING. IT HAS JUST FIRED IN REVERSE ON ITS OWN 3 SEPARATE TIMES NOW. AND AFTER WE HAVE HAD THE CUP IN ON A COUPLE OCCASIONS IT HAS BACKED THE CUP OUT WITHOUT THE DR PRESSING ANY OF THE BUTTONS CAUSING THE CUP TO LOSE ITS PRESS FIT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR WHETHER A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23513015 ↗
• MalfunctionNov 3, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE GUN OF THE IMPACTOR DEVICE MISFIRED IN REVERSE, WITHOUT THE SURGEON PRESSING ANY OF THE BUTTONS, CAUSING THE IMPACTOR CUP TO BACK OUT AND LOSE ITS PRESS FIT. 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 2025. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23459727 ↗
• MalfunctionNov 3, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE GUN OF THE IMPACTOR DEVICE MISFIRED IN REVERSE, WITHOUT THE SURGEON PRESSING ANY OF THE BUTTONS, CAUSING THE IMPACTOR CUP TO BACK OUT AND LOSE ITS PRESS FIT. 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 2025. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23459714 ↗
• MalfunctionSep 11, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE REVERSE BUTTON ON THE SURGICAL HANDPIECE DEVICE WAS STUCK. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. 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 23027093 ↗
• MalfunctionSep 9, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE KINCISE IMPACTOR DEVICE WOULD FIRE TWICE WHEN THE TRIGGER WAS PULLED. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE DEVICE TRIGGER WAS STICKY, THIS LED THE DEVICE TO KEEP FIRING AFTER THE TRIGGER WAS RELEASED. THE DEVICE ALSO INCREASED THE FREQUENCY OF IMPACT. THE DEVICE ALSO FAILED PRETESTS FOR OPERATION ASSESSMENT. 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 23005650 ↗
• MalfunctionSep 9, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING PRE-SURGERY TESTING IT WAS OBSERVED THAT THE TRIGGER OF THE IMPACTOR DEVICE WAS STUCK. THIS EVENT DID NOT OCCUR DURING SURGERY. 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 23004235 ↗
• MalfunctionSep 9, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING PRE-SURGERY TESTING IT WAS OBSERVED THAT THE TRIGGER OF THE IMPACTOR DEVICE WAS STUCK. THIS EVENT DID NOT OCCUR DURING SURGERY. 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 23003461 ↗
• MalfunctionSep 4, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE IMPACTOR DEVICE AUTO FIRED AND WAS FIRING WHILE THE SURGEON WAS NOT PULLING THE TRIGGER. IT WAS REPORTED THAT THE DEVICE WAS NO LONGER USED AND A REPLACEMENT WAS REQUESTED. THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE ISSUE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22963795 ↗
• MalfunctionJul 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE IMPACTOR DEVICE SCREW POPPED OUT OF THE LATCH THAT HOLDS THE BATTERY IN. THERE WERE NO DELAYS AND A BACKUP WAS AVAILABLE FOR USE. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22664846 ↗
• MalfunctionJul 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE TOP REVERSE BUTTON OF THE IMPACTOR DEVICE POPPED OFF. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE PROCEDURE DUE TO THE EVENT. 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 22629810 ↗
• MalfunctionJul 23, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE KINCISE SURGICAL AUTOMATED SYSTEM DEVICE HAD AN UNKNOWN ALLEGATION. DURING FURTHER FOLLOW UP WITH THE REPORTER IT WAS REPORTED THAT THE TRIGGER WAS STUCK IN REVERSE. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22576350 ↗
• MalfunctionJul 9, 2025Appropriate Device Problem Term/Code Not Available; Physical Resistance/Sticking; Appropriate Device Problem Term/Code Not Available; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING PRE-SURGERY, IT WAS DISCOVERED THAT THE TRIGGER OF THE HANDPIECE DEVICE WAS STICKING AND NOT WORKING CORRECTLY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. 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 22461004 ↗
• MalfunctionJul 7, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING TESTING, IT WAS OBSERVED THAT THE SURGICAL HANDPIECE DEVICE TRIGGER WAS LOCKED IN REVERSE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. 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 22412326 ↗