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Medicon 58.60.08Recalls & reported problems

Medicon eG. Chirurgiemechaniker-Genossenschaft · Yasargil Stand Ti clip str 7mm p · Class 2 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046826094171), received between Nov 10, 2018 and Nov 10, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Handling 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Device Handling Problem2
  • Material Twisted/Bent2
  • Fracture1

Patient problems

  • No Known Impact Or Consequence To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 10, 2018Material Twisted/Bent; Device Handling Problem; Material Twisted/Bent; Device Handling Problem

    APPLICATION OF EXCESSIVE FORCE TO THE JAW PART OF THE CLIP DURING A SURGICAL PROCEDURE CAUSED CLIP JAW MISALIGNMENT AND IMPAIRED CLIP FUNCTION BY MAKING IT IMPOSSIBLE TO CLOSE THE CLIP PROPERLY. THE PATIENT DID NOT SUFFER ANY HARM. NO FURTHER INFORMATION HAS BEEN PROVIDED BY THE DISTRIBUTOR, WHO FIRST INDICATED THAT THE MALFUNCTION OCCURRED DURING USE OF THE DEVICE, AND THEN THAT IT WAS DAMAGED DURING CLEANING AND STERILIZATION PRIOR TO FIRST USE. THE SECOND STATEMENT DOES NOT HOLD, SINCE THE RETURNED DEVICE SHOWED TRACES OF BLOOD.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8058151 ↗
  • MalfunctionNov 10, 2018Fracture; Material Twisted/Bent; Device Handling Problem; Fracture; Material Twisted/Bent; Device Handling Problem

    DURING A SURGICAL PROCEDURE, UNDUE FORCE SEEMS TO HAVE BEEN APPLIED TO THE CLIP WITH A FOREIGN OBJECT, LEADING TO BREAKAGE. THE PATIENT DID NOT SUFFER ANY HARM. NO FURTHER INFORMATION HAS BEEN PROVIDED BY THE DISTRIBUTOR, WHO FIRST INDICATED THAT THE MALFUNCTION OCCURRED DURING USE OF THE DEVICE, AND THEN THAT IT BROKE DURING CLEANING AND STERILIZATION PRIOR TO FIRST USE. THE SECOND STATEMENT DOES NOT HOLD, SINCE THE RETURNED DEVICE SHOWED TRACES OF BLOOD.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8058035 ↗

Other CLIP, ANEURYSM devices

All CLIP, ANEURYSM devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.