n.a. 27040NB-SRecalls & reported problems
Karl Storz GmbH & Co. KG · 24FR BIPLR COAG ELECTRDE, STERILE · Class 2
Data updated Oct 16, 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 04048551393987), received between Jul 10, 2025 and Jul 10, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
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.
MalfunctionJul 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE ELECTRODES WHERE THEY ARE SPLIT IN THE PACKAGE (UNOPENED) AND THEREFORE, ENCOUNTERS ISSUES DURING PROCEDURES, LIKE GETTING STUCK OR THE LOOP NOT COMING ALL THE WAY BACK IN. I WAS NOT NOTIFIED OF ANY PATIENT EVENTS ETC BUT HAD A SURGEON TELL ME THE LOOPS KEEP GETTING STUCK, WONT COMPLETE CUTS. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. ACCORDING TO THE ISSUE DESCRIPTION THERE IS NO INDICATION THAT ANY PARTS HAVE DETACHED FROM THE ELECTRODES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22470639 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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