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LiNA Bipolar Loop™ BL-160Recalls & reported problems

Lina Medical ApS · Endoscopic Bipolar Loop for Laparoscopic Supracervical Hysterectomy and Myomectomy. Small Loop- 160x80mm · 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 05708265004607), received between Oct 5, 2018 and Oct 5, 2018 — 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.

  • MalfunctionOct 5, 2018Break

    ALLEGEDLY, 2EA BL-160 BROKE DURING SURGERY.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7937740 ↗

Other Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) devices

All Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) devices →

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