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AESCULAP FK882RRecalls & reported problems

Aesculap AG · KAIRISON Bone Punch pneumatic, upwards cutting, 9 1/4", (235 mm), working length: 5 1/2", (140 mm), width: 2 mm, opening width: 12 mm, detachable, with ejector, non-sterile, reusable, to be used with: FK891R · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046963323516), received between Apr 6, 2021 and Apr 6, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Material Twisted/Bent1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 6, 2021Material Twisted/Bent; Material Twisted/Bent

    ADDITIONAL INFORMATION RECEIVED ON 04/07/2021. THE DEVICE MALFUNCTION WAS NOTED BY THE SURGICAL STAFF PRIOR TO USE ON THE PATIENT. THE REPORTER ADDED THAT THERE WAS A SECOND SET AVAILABLE FOR USE, AS SUCH THE 2MM KAIRISON WAS REMOVED FROM USE AND AN ALTERNATIVE KAIRISON READILY AVAILABLE TO USE IN THE PROCEDURE. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO INTRAOPERATIVE ISSUES OR EVENTS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11618856 ↗

Other RONGEUR, POWERED devices

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Sources and updates

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