DW ARTHROSCOPY FLUID MANAGEMENT DEV
Received Jul 30, 2026 · Event occurred Jul 13, 2026
Report 1220246-2026-04111 · MDR key 50083092
Device
Generic name
Arthroscope And Accessories
Manufacturer
Arthrex, Inc.Model number
DW ARTHROSCOPY FLUID MANAGEMENT DEVCatalog number
AR-6480
Lot number
32342712
Product problems
- Increase in Pressure
Patient
Unknown
- Joint Dislocation
Narrative
Description of Event or Problem
On 10-June-2026, it was reported by a Sales Representative via (b)(4) that an AR-6480 pump over pressured and expanded the shoulder joint. This occurred during use in a shoulder arthroscopy case with no patient effect.The pressure was set to 50. The pump shut off and an unknown alarm sounded. A different pump was used to complete the procedure. There was no revision to remove extra fluid and the patient was not kept at the facility for fluid removal.
Additional Manufacturer Narrative
Investigation is in process. A follow-up report will be provided upon availability of additional information.