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IMAGE 1 S TH116Recalls & reported problems

Karl Storz GmbH & Co. KG · IMAGE1 S D1 · 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 04048551356876), received between Jun 22, 2018 and Jun 22, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Signal Artifact/Noise” (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

  • Signal Artifact/Noise1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionJun 22, 2018Signal Artifact/Noise; Signal Artifact/Noise

    ALLEGEDLY, DURING A MEDIASTINOSCOPY PROCEDURE, THERE WAS INTERFERENCE ON THE SCREEN WHEN CAUTERY WAS USED. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITH NO PATIENT IMPACT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7631903 ↗

Other Endoscopic video imaging system/component, gastroenterology-urology devices

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