LiNA Gold Loop™ EL-160-8Recalls & reported problems
Lina Medical ApS · Endoscopic Monopolar Loop for LSH. Small loop- 160-80mm, 8mm connector · Class 2
Data updated Oct 18, 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 05708265001316), received between Sep 24, 2026 and Sep 24, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
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.
MalfunctionSep 24, 2026Fracture
Narrative provided by the distributor: "Allegedly, the photo below shows the Loop after it was damaged".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50880735 ↗
Other Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) devices
- Olympus WA47786AOLYMPUS Winter & Ibe GmbH · Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)14 reports
- n.a. 37370DLKarl Storz GmbH & Co. KG · COAGULATOR-CUTTER, ENDOSCOPIC, UNIPOLAR (AND ACCESSORIES)13 reports
- n.a. 26183MC-SKarl Storz GmbH & Co. KG · COAGULATOR-CUTTER, ENDOSCOPIC, UNIPOLAR (AND ACCESSORIES)12 reports
- Sonata® Radiofrequency Ablation Handpiece RFA-002Gynesonics, Inc. · Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)12 reports
- n.a. 26183MD-SKarl Storz GmbH & Co. KG · COAGULATOR-CUTTER, ENDOSCOPIC, UNIPOLAR (AND ACCESSORIES)7 reports
- Sonata® Dispersive Electrode DE-001Gynesonics, Inc. · Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)3 reports
- Integra® Jarit® 600305Integra Lifesciences Production Corporation · COAGULATOR-CUTTER, ENDOSCOPIC, UNIPOLAR (AND ACCESSORIES)3 reports
- AESCULAP PO615RAesculap AG · COAGULATOR-CUTTER, ENDOSCOPIC, UNIPOLAR (AND ACCESSORIES)2 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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