n.a. 26040JB1-SRecalls & reported problems
Karl Storz GmbH & Co. KG · CUTTING LOOP, BIPOLAR, 24/26FR · Class 2
Data updated Oct 13, 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 04048551393161), received between Jun 19, 2020 and Jun 19, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
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 19, 2020Break
AS PER AN AER RECEIVED FROM (B)(6) BY THE FACTORY IN (B)(4), INVOLVING A BIPOLAR CUTTING LOOP: BREAK INSIDE THE UTERUS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10175273 ↗
Other COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR (AND ACCESSORIES) devices
- Olympus WA47787AOLYMPUS Winter & Ibe GmbH · Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)32 reports
- n.a. 26040GP1-SKarl Storz GmbH & Co. KG · COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR (AND ACCESSORIES)30 reports
- n.a. 26055GP1-SKarl Storz GmbH & Co. KG · COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR (AND ACCESSORIES)3 reports
- LiNA Bipolar Loop™ BL-200Lina Medical ApS · Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)3 reports
- LiNA Bipolar Loop™ BL-160Lina Medical ApS · Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)1 report
- Olympus WA47790AOLYMPUS Winter & Ibe GmbH · Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)1 report
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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