n.a. 628001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551001240), received between Dec 15, 2025 and Dec 15, 2025 — classified as 2 injuries.

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

• InjuryDec 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF A SICKLE KNIFE BROKE OFF IN A PATIENT'S NOSE DURING OPERATION. THE TIP WAS TOO SMALL AND COULD NOT BE RECOVERED. SINCE THE TIP COULD NOT BE RETRIEVED, THE CASE IS DEEMED AS REPORTABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23804815 ↗
• InjuryDec 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF A SICKLE KNIFE BROKE OFF IN A PATIENT'S NOSE DURING OPERATION. THE TIP WAS TOO SMALL AND COULD NOT BE RECOVERED. SINCE THE TIP COULD NOT BE RETRIEVED, THE CASE IS DEEMED AS REPORTABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23804814 ↗