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

Catalog Number 8000.COM03

Device Problem Output below Specifications (3004)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/03/2022

Event Type  malfunction  

Event Description

We have been informed that during a retina procedure, the surgeon was not getting good marks on the retina from the laser.Two laser probes of different lot number were opened with the same low output.The power was 200mw and had to be increased to 500mw to see marks.The surgeon had to use cryo because he did not feel comfortable using the laser.Due to the reported event, surgery was prolonged > 30 minutes.No report that actual patient harm occurred.

Manufacturer Narrative

The complaint is under investigation.

Manufacturer Narrative

Following up to this event, the customer was requested to return the item subject to this event for investigation.We received confirmation that the product has been shipped.Once the product is available, the investigation will be performed in order to determine the rootcause of the reported event.

Event Description

We have been informed that during a retina procedure, the surgeon was not getting good marks on the retina from the laser.Two laser probes of different lot number were open with the same low output.The power was 200mw and had to be increased to 500mw to see marks.The surgeon had to use cryo because he did not feel comfortable using the laser.Due to the reported event, surgery was prolonged > 30 minutes.No report that actual patient harm occurred.

Manufacturer Narrative

In regards to this complaint a laser interface and laser mainhouse were received.Opening of the laser interface revealed that there was tissue paper on the lens.The interface front was probably cleaned and a piece of the cleaning material got stuck in the port and was pushed in while inserting a laser probe.The laser mainhouse showed no deviations and was working according to release specifications.Most likely this incident was caused by the user cleaning the eva system.Trend analysis indicates that the product is performing within anticipated rates.Therefore, no remedial or corrective/preventive actions will be undertaken at this moment.Complaints will be closely monitored to identify any significant adverse trends.All similar incidents related to the eva surgical system are included in the analysis (eva-low-surgery-not res and eva-low-surgery-prolonged).Since 2019 more than 850.000 surgeries have been performed with the eva surgical systems installed.

Event Description

We have been informed that during a retina procedure, the surgeon was not getting good marks on the retina from the laser.Two laser probes of different lot number were open with the same low output.The power was 200mw and had to be increased to 500mw to see marks.The surgeon had to use cryo because he did not feel comfortable using the laser.Due to the reported event, surgery was prolonged > 30 minutes.No report that actual patient harm occurred.

• 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: 15678508
• MDR Text Key: 304913268
• Report Number: 1222074-2022-00077
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/10/2022

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.COM03
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/27/2022
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/19/2022; 02/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1