EVA
Report
- Report Number
- 1222074-2022-00088
- Event Type
- Malfunction
- Date Received
- December 14, 2022
- Date of Event
- November 24, 2022
- Report Date
- February 7, 2023
- Manufacturer
- D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER
- Product Code
- HQC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
IN REGARD TO THIS COMPLAINT, AN EVA VITRECTOMY MODULE WAS RETURNED FOR INVESTIGATION. INVESTIGATION OF THIS MODULE REVEALED THAT CUTTER VALVES INSIDE THE MODULE WERE STUCK DUE TO THE PRESENCE OF AN OIL-LIKE SUBSTANCE. DUE TO THE STUCK VALVES, THE MODULE COULD NOT FUNCTION WITHIN THE SPECIFICATIONS. THE ORIGIN OF THIS OIL-LIKE SUBSTANCE COULD NOT BE DETERMINED.
THE COMPLAINT IS UNDER INVESTIGATION
WE HAVE BEEN INFORMED THAT DURING PROCEDURE, THE HANDPIECE OF VITRECTOME DID NOT CUT. THE USER TRIED THREE VITRECTOMY PACKS FROM TWO DIFFERENT BATCHES AND THEY DID NOT SOLVE THE PROBLEM. THE USER STATES THAT THE VITRECTOMY MODULE SOUNDED WEIRD. THE USER WAS NOT ABLE TO SOLVE THE ISSUE AND IT WAS DECIDED TO ABORT THE SURGERY. NO REPORT THAT ACTUAL PATIENT HARM OCCURRED.
WE HAVE BEEN INFORMED THAT DURING PROCEDURE, THE HANDPIECE OF VITRECTOME DID NOT CUT. THE USER TRIED THREE VITRECTOMY PACKS FROM TWO DIFFERENT BATCHES AND THEY DID NOT SOLVE THE PROBLEM. THE USER STATES THAT THE VITRECTOMY MODULE SOUNDED WEIRD. THE USER WAS NOT ABLE TO SOLVE THE ISSUE AND IT WAS DECIDED TO ABORT THE SURGERY. NO REPORT THAT ACTUAL PATIENT HARM OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 474465 | EVA | EVA | HQC | D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |