MEDLINE 5DCSRRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888277408746), received between Jun 26, 2026 and Sep 24, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Arcing” (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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Overheating of Device; Arcing; Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889979 ↗
• MalfunctionAug 7, 2026Material Separation; Detachment of Device or Device Component

  It was reported that the physicians will use them to cut the duct on a gallbladder and the instrument will come apart. The plastic pieces come apart and it doesn't work.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50178721 ↗
• MalfunctionJun 26, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT, THE INSULATION AT THE TIP OF THE DEVICE IS GETTING STUCK IN THE 5 MM PORTS AND STARTING TO TEAR WHEN THEY USE THE DEVICE. A NEW DEVICE WAS OPENED TO REPLACE BAD PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25644356 ↗