SCORPION NEEDLE
Received Feb 13, 2018 · Event occurred Jan 29, 2018
Report 3032391-2018-00002 · MDR key 7267124
Device
Product problems
- Detachment Of Device Component
Patient
Not reported
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT A REPROCESSED NEEDLE TIP DETACHED DURING A SHOULDER ARTHROSCOPY PROCEDURE. THE SURGEON WAS ABLE TO LOCATE THE DETACHED TIPS AND RETRIEVE THEM FROM THE PATIENT WITHOUT FURTHER INCIDENT. THE DEVICE INVOLVED IN THE INCIDENT WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED. THE CUSTOMER REPORTED ISSUE OF A REPROCESSED NEEDLE TIP DETACHING WAS NOT CONFIRMED; THEREFORE NO ROOT CAUSE HAS BEEN DETERMINED AT THIS TIME. ADDITIONALLY, THE LOT NUMBER WAS NOT PROVIDED, THEREFORE A REVIEW OF THE REPROCESSING RECORDS COULD NOT BE PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE. DUE TO THE REPORTED INCIDENT AND SUBSEQUENT NEED FOR SURGICAL INTERVENTION, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT A REPROCESSED NEEDLE TIP DETACHED DURING A PATIENT PROCEDURE.