MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. EVA; PHACOEMULSIFICATION/VITRECTOMY SYSTEM

Catalog Number 8000.COM05

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Insufficient Information (4580)

Event Date 07/21/2022

Event Type  malfunction  

Manufacturer Narrative

The complaint is under investigation.

Event Description

It was reported that an unstable iop was encountered during procedure.Due to this event the eye collapsed.No actual patient harm was reported.In addition, the issue encountered did not result in a prolonged or delayed surgery.

Manufacturer Narrative

With regard to this event logfiles were provided for review.Review of the log files of the eva system involved revealed a possible issue with the supplied input air.As included in the eva instruction manual section a1.2 "eva environmental specifications" the requirements of the air input are specified to be 4 to 10 bar with a flow rate of 60 to 70 nl/min.During an on-site inspection, the pressure of compressed air and the manometer were checked and re-adjusted.This solved the problem.It should be noted that the issue persisted also on another eva system (case 2022-006860) and also for this eva the issue was solved after the pressure of compressed air and the manometers were re-adjusted.Review of the complaint database indicated that no similar issues have been logged on the eva surgical system subject to this event.Since the problem did not re-occur and no module was replaced, it is considered that the event was triggered due to a too low flow rate or pressure of the input air supplied by the hospital.

Event Description

It was reported that an unstable iop was encountered during procedure.Due to this event the eye collapsed.No actual patient harm was reported.In addition, the issue encountered did not result in a prolonged or delayed surgery.

• Brand Name: EVA
• Type of Device: PHACOEMULSIFICATION/VITRECTOMY SYSTEM
• Manufacturer (Section D): D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.; scheijdelveweg 2; zuidland, 3214 VN; NL 3214 VN
• Manufacturer (Section G): D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.; scheijdelveweg 2; zuidland, 3214 VN; NL 3214 VN
• Manufacturer Contact: danielle sleegers ; scheijdelveweg 2; zuidland, 3214 -VN ; NL 3214 VN
• MDR Report Key: 15238851
• MDR Text Key: 298078276
• Report Number: 1222074-2022-00057
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: IR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8000.COM05
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/17/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1