V. MUELLER
Received Apr 3, 2026 · Event occurred Mar 3, 2026
Report 3006554912-2026-00004 · MDR key 24778979
Device
Generic name
Henly Retractor Set
Manufacturer
Steris Deutschland GmbhModel number
CH1030Catalog number
CH1030
Lot number
(10)D25XBH
Product problems
- Insufficient Device Problem Information
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE SUBJECT OF THE REPORTED EVENT IS BEING RETURNED FOR EVALUATION. INVESTIGATION OF THE EVENT IS CURRENTLY IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE BLADES TO THEIR HENLY RETRACTOR SET DID NOT "FIT ON THE NEW FRAME". USER FACILITY PERSONNEL UTILIZED ANOTHER HENLY RETRACTOR SET AND THE PATIENT PROCEDURE WAS COMPLETED SUCCESSFULLY FOLLOWING A SHORT DELAY. NO REPORT OF INJURY.