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LiNA Xcise™, Laparoscopic Morcellator MOR-1515-6Recalls & reported problems

Lina Medical ApS · 15mm battery powered morcellator system with obturator · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05708265004706), received between Nov 27, 2018 and Jun 27, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Shut Off” (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.

Most reported problems

Device problems

  • Appropriate Device Problem Term/Code Not Available1
  • Failure to Shut Off1
  • Therapeutic or Diagnostic Output Failure1

Patient problems

  • No Consequences Or Impact To Patient1
  • Tissue Damage1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 27, 2019Failure to Shut Off; Therapeutic or Diagnostic Output Failure

    "ALLEGEDLY, THE MORCELLATOR MALFUNCTIONED IN THE MIDDLE OF THE CASE. THE SURGERY FELLOW TRIED TO TURN OFF THE MORCELLATOR, BUT WAS UNABLE TO STOP THE SPIN OF THE BLADE. SHE EVENTUALLY GOT IT TO STOP, AND THE PATIENT WAS UNHARMED, BUT THE FELLOW WAS UNCOMFORTABLE WITH USING IT AGAIN."

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8738374 ↗
  • MalfunctionNov 27, 2018Appropriate Device Problem Term/Code Not Available

    MALFUNCTIONING EQUIPMENT: LINA XCISE (NO SPECIFICS ON THE 'MALFUNCTION' FROM REPORTER). NO HARM TO THE PATIENT. AN ESPINER BAG WAS PLACED THROUGH THE UMBILICAL TROCAR FOR MORCELLATION WITHIN A PSEUDOPNEUMOPERITONEUM. THE SPECIMEN PLACED WITHIN THE BAG AND THE BAG SECURED THROUGH THE UMBILICAL INCISION. THE PSEUDOPNEUMOPERITONEUM WAS ESTABLISHED WITHIN THE BAG AND A 5 MM TROCAR WAS PLACED INTO THE BAG FROM THE LATERAL TROCAR SITE. THE BALLOON WAS INFLATED AND SECURED THIS TROCAR IN PLACE. THE MORCELLATOR WAS PLACED AT THE UMBILICAL TROCAR SITE WITHIN THE ESPINER BAG. THE UTERUS WAS MORCELLATED AND REMOVED FROM THE PELVIS. THE BAG WAS THEN REMOVED. PNEUMOPERITONEUM WAS REESTABLISHED. THE PATIENT'S PELVIS WAS INSPECTED AND HEMOSTASIS WAS CONFIRMED. NO COMPLICATIONS.

    Patient problems: Tissue Damage

    MAUDE report 8107708 ↗

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Sources and updates

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