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CLICKLINE 33300WRecalls & reported problems

Karl Storz GmbH & Co. KG · Metal Outer Sheath, insulated, 36 cm · Class 2

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04048551133972), received between Jan 24, 2019 and Jan 24, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Material Deformation” (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 Deformation1
  • Material Fragmentation1

Patient problems

  • Foreign Body In Patient1

Recent adverse event reports

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

  • InjuryJan 24, 2019Material Fragmentation; Material Deformation; Material Fragmentation; Material Deformation

    WE RECEIVED A VIGILANCE REPORT FROM OUR MANUFACTURER IN (B)(6) WHICH WAS FILED WITH THE NATIONAL COMPETENT AUTHORITY, (B)(6) IN (B)(6). ALLEGEDLY, A FEMALE PATIENT UNDERWENT A LAP CHOLE PROCEDURE ON (B)(6) 2018. A MONTH AFTER THE PROCEDURE, THE PATIENT COMPLAINED ABOUT ABDOMINAL PAIN IN THE OPERATED REGION. A SUBSEQUENT CT SCAN SHOWED A 4MM METAL FRAGMENT SITUATED BELOW THE UMBILICUS. A SECOND PROCEDURE TO REMOVE THE FRAGMENT WAS PERFORMED ON (B)(6) 2018.

    Patient problems: Foreign Body In Patient

    MAUDE report 8276481 ↗

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Sources and updates

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