NA 8488041Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04055207017760), received between Jul 27, 2023 and Jul 27, 2023 — classified as 1 injury.

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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2023Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  THE USER FACILITY HAS INFORMED RICHARD WOLF GMBH OF AN ISSUE REGARDING A HOOK SCISSORS Ø 3.4MM, PART ID: 8488041, LOT # UNKNOWN. ACCORDING TO THE RECEIVED INFORMATION FROM THE CUSTOMER, LE DR RUH, "REPORT INTRAOPERATIVE BREAKAGE OF A PAIR OF ARTHROSCOPIC SCISSORS WITH LOSS OF PART OF THE INSTRUMENT IN THE JOINT." THE REPORTER CLAIMED THAT THE PRESENCE OF THE METALLIC ELEMENT IN THE JOINT IS A CONTRAINDICATION FOR AN MR/EXAMINATION. THEREFORE, THE POSSIBILITY OF RECOVERING THE EXOGENOUS ELEMENT IS IMPOSSIBLE. THE PATIENT OUTCOME IS NEGATIVE AND THE LONG TERM CONSEQUENCES IS UNKNOWN. THIS CASE WAS REPORTED BY THE CUSTOMER TO THE FRENCH NATIONAL AGENCY FOR THE SAFETY OF MEDICINES AND HEALTH PRODUCTS (ANSM).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 17406295 ↗