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n.a. 26175BLRecalls & reported problems

Karl Storz GmbH & Co. KG · Myoma Fixation Instrument · Class 2

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 04048551099063), received between Aug 30, 2017 and Aug 30, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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 Separation1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionAug 30, 2017Material Separation; Material Separation

    ALLEGEDLY, THE DOCTOR WAS PERFORMING A MYOMECTOMY PROCEDURE WHEN THE TIP OF THE MYOMA FIXATION INSTRUMENT BROKE OFF IN A FIBROID. THE DOCTOR REMOVED THE FIBROID THAT ENCASED THE BROKEN PIECE AND COMPLETED PROCEDURE. THE HOSPITAL REPORTED THERE WAS NO INJURY TO THE PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6831495 ↗

Other LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) devices

All LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) devices →

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