n.a. 26167FNRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04048551095348), received between Mar 3, 2020 and Mar 23, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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

Recent adverse event reports

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

• InjuryMar 23, 2023Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  THE PROCEDURE WAS PROLONGED FOR ABOUT ONE HOUR DUE TO THE EVENT REPORTED. THE INITIAL ANTICIPATED SURGERY TIME IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16599565 ↗
• InjuryMar 23, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH ULTRAMICRO NEEDLE HOLDER, 30 CM, DURING SURGERY. ACCORDING TO THE COMPLAINT DESCRIPTION A METAL FRAGMENT WAS FOUND IN SITU DURING SURGERY. THE NEEDLE HOLDER WAS USED TO SUTURE THE COLON WALL (SIGMA). AFTER FINISHING THE SUTURE, THE PRESENCE OF A METAL FRAGMENT ON THE WALL OF AN INTESTINAL LOOP WAS FOUND AND IT WAS REMOVED. THE CONSEQUENCE WAS A PROLONGED SURGERY TIME AND EXECUTION OF ABDOMINAL X-RAY. THE SURGERY WAS COMPLETED SUCCESSFULLY AND NO NEGATIVE IMPACT ON THE STATE OF HEALTH WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16599563 ↗
• MalfunctionMar 3, 2020Material Fragmentation; Material Fragmentation

  AS PER A VIGILANCE REPORT FILED WITH THE (B)(6) BY THE FACTORY IN (B)(4), ONE OF OUR PEDIATRIC NEEDLE HOLDERS FAILED DURING USE; THE TRIANGULAR GRIP ON ONE OF THE JAWS OF THE NEEDLE HOLDER CAME OFF AND AN X-RAY CONFIRMED BY IT WAS IN THE CHILD. IT IS UNKNOWN AT THIS TIME IF THE PIECE HAS BEEN REMOVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9781618 ↗