GENTUITY HF-OCT IMAGING SYSTEM
Received Jun 1, 2026 · Event occurred Oct 6, 2022
Report 3011578544-2026-00040 · MDR key 25355372
Device
Generic name
System, Imaging, Optical Coherence Tomogragphy (oct)
Manufacturer
Gentuity, LlcModel number
G10-01Catalog number
G10-01
Lot number
22E0204
Product problems
- Improper or Incorrect Procedure or Method
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
DR. (B)(6), PART A PA STUDY: THE FIRST ATTEMPT OF AN ACQUISITION TIME OUT ON CALIBRATION AND THE STAFF TRIED IT A SECOND TIME WITH A SUCCESSFUL IMAGE ACQUIRED. NO INTERVENTION WAS PERFORMED, SO THE CASE WAS ENDED. POST PROCEDURE, (B)(6), (RESEARCH COORDINATOR) ATTEMPTED TO RELEASE THE VIS RX CATHETER FROM THE PIM AND THE PULLBACK PORTION OF THE CATHETER WOULD NOT RELEASE. (B)(6) CALLED ME AGAIN ON WHATSAPP VIDEO CHAT AND I TALKED HER THROUGH TROUBLE SHOOTING WITH NO SUCCESS. I ASKED HER TO SHUT DOWN THE CONSOLE AND SHE STATED THAT IT STILL WOULDN¿T RELEASE. SHE CALLED ME BACK ONCE AGAIN AND SAID THAT IT RELEASED AS SOON AS THE CONSOLE WAS FULLY POWERED DOWN. NO INJURIES TO THE PATIENT OR OTHER EVENTS RESULTED FROM THIS COMPLAINT.
Additional Manufacturer Narrative
AFTER THE CASE, THE CATHETER COULD NOT BE RELEASED FROM THE PIM. REVIEW CONFIRMED THE CATHETER WAS REMOVED BEFORE THE PIM DISCONNECTION CYCLE WAS COMPLETE OR WITHOUT BOTH RELEASE BUTTONS PRESSED. THE PIM LOCK DID NOT DISENGAGE, PREVENTING REMOVAL. ONCE THE CONSOLE FULLY POWERED DOWN, THE CATHETER RELEASED NORMALLY. COMPLAINT CONFIRMED AS USE ERROR; NO PATIENT IMPACT.