KINCISE™ 1010-01-101Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00845384018551), received between Nov 29, 2022 and Oct 24, 2023 — classified as 4 malfunctions.

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

• MalfunctionOct 24, 2023Break; Device-Device Incompatibility; Mechanical Jam; Break; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT THE ADAPTER DEVICE WAS GETTING STUCK ON THE CORAIL BROACHES. IT WAS FURTHER REPORTED THAT ALL THE PIECES WERE RECOVERED, AND THE ADAPTERS WERE WORN DOWN. 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 FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. 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 17995937 ↗
• MalfunctionOct 24, 2023Break; Device-Device Incompatibility; Mechanical Jam; Break; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT THE ADAPTER DEVICE WAS GETTING STUCK ON THE CORAIL BROACHES. IT WAS FURTHER REPORTED THAT ALL THE PIECES WERE RECOVERED, AND THE ADAPTERS WERE WORN DOWN. 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 FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. 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 17995827 ↗
• MalfunctionOct 23, 2023Break; Device-Device Incompatibility; Mechanical Jam; Break; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT THE BROACH ADAPTER-STRAIGHT DEVICE WAS GETTING STUCK ON THE CORAIL BROACH DEVICE. IT WAS REPORTED THAT ALL PIECES WERE RECOVERED. IT WAS REPORTED THAT THE BROACH ADAPTERS WERE WORE DOWN. IT WAS NOT REPORTED IF THE EVENT OCCURRED DURING A SURGICAL PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A DELAY TO A PLANNED PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A SPARE DEVICE AVAILABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED. 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 17988314 ↗
• MalfunctionNov 29, 2022Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  THIS IS REPORT 1 OF 3 OF THE SAME EVENT: IT WAS REPORTED FROM UNITED KINGDOM THAT DURING A DEVICE DEMONSTRATION, IT WAS OBSERVED THAT THE BROACH ADAPTER DEVICES WERE STIFF, AND ANOTHER INSTRUMENT HAD TO BE USED TO SEPARATE THE BROACHES FROM THE ADAPTERS ONCE THEY WERE LOCKED IN. THE EVENT WAS NOT RELATED TO SURGERY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. 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 15879667 ↗