XPAND X1 IRIS SPECULUM
Received Jul 2, 2026 · Event occurred Apr 17, 2026
Report 3000892087-2026-00001 · MDR key 25692326
Device
Generic name
Xpand X1 Iris Speculum
Manufacturer
International Science And Technology, LpModel number
346722Catalog number
346722
Lot number
42752
Product problems
- Mechanical Problem
- Ejection Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ON (B)(6) 2026, A CUSTOMER REPORTED THAT XPAND X1 RING DID NOT BEHAVE CORRECTLY. THE CUSTOMER PROVIDED A VIDEO, AND IT CAN BE SEEN THAT THE RING WAS TWISTED UPON DEPLOYMENT. NO PATIENT WAS HARMED, AS THE CUSTOMER STATED THAT THEY CAN ANTICIPATE WHEN THE RING IS NOT BEHAVING PROPERLY. THE DEVICE WAS DISCARDED AND NOT AVAILABLE FOR PHYSICAL EVALUATION. REVIEW OF AVAILABLE PMS AND BATCH DOCUMENTATION IDENTIFIED A POTENTIAL ROOT CAUSE OF IMPROPER LOADING OF THE RING INTO THE INJECTOR.
Description of Event or Problem
IT WAS REPORTED THAT THE XPAND X1 RING DID NOT BEHAVE CORRECTLY. THE RING WAS TWISTED UPON DEPLOYMENT. NO PATIENT WAS HARMED, AS THE CUSTOMER STATED THAT THEY CAN ANTICIPATE WHEN THE RING IS NOT BEHAVING PROPERLY.
Remedial action
- Replace