MalfunctionHCF
M-CLOSE KIT
Received Jun 18, 2025 · Event occurred Jun 9, 2025
Report 22282728 · MDR key 22282728
Device
Generic name
Instrument, Ligature Passing And Knot Tying
Manufacturer
New Wave Endo-surgery Inc.Model number
27-101Catalog number
27-101
Lot number
E1325
Product problems
- Retraction Problem
Patient
75 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
WHEN THE M-CLOSE DEVICE WAS ENGAGED, THE NEEDLES WOULD NOT RETRACT WHEN THE WHITE BUTTON WAS PUSHED (AS PER PROTOCOL). THE VICRYL TIE USED WITH THE DEVICE WAS CUT OUT AND PULLED OUT OF THE DEVICE IN AN ATTEMPT TO GET THE NEEDLES TO RETRACT, BUT THAT DID NOT WORK. THE PROVIDER WAS ABLE TO PULL THE M-CLOSE DEVICE OUT OF THE INCISION SITE WITHOUT HARM TO THE PATIENT. THE DEVICE WAS REMOVED FROM USE AND THE SURGICAL FIELD AT THAT TIME.