HOOK SCISSORS Ø 3.4MM
Received Jul 27, 2023 · Event occurred Jun 22, 2023
Report 9611102-2023-00050 · MDR key 17406295
Device
Generic name
Hook Scissors Ø 3.4mm
Manufacturer
Richard Wolf GmbhModel number
8488041Catalog number
8488.041
Lot number
UNKNOWN
Product problems
- Material Separation
- Detachment of Device or Device Component
- Material Separation
- Detachment of Device or Device Component
Patient
Unknown
- Foreign Body In Patient
- Insufficient Information
- Foreign Body In Patient
- Insufficient Information
Narrative
Additional Manufacturer Narrative
INSTRUMENT HAS NOT YET BEEN SENT FOR EXAMINATION BY THE USER. AS SOON AS THE INSTRUMENT IS IN HOUSE, THE EXAMINATION WILL BE STARTED. SO FAR, THERE HAS BEEN NO COMPARABLE CASE OF THIS TYPE.
Description of Event or Problem
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).