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

Catalog Number 8000.COM03

Device Problems Output Problem (3005); Positioning Problem (3009)

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

Event Date 06/25/2021

Event Type  malfunction  

Manufacturer Narrative

The product will be returned for investigation.

Event Description

We have been informed that the or staff was setting up the machine and could not turn it on.General anesthesia was already administered.Due to the reported event surgery was prolonged with >30 minutes.No actual patient harm occurred.

Manufacturer Narrative

The product has been returned for investigation.No corrective or preventive actions can be implemented until the investigation has been completed.In regard to this event an eva power supply was returned for investigation.Investigation of the returned power supply did not reveal any anomalies.The power supply performed within the release specification.Therefore, the event cannot be attributed to a defect of the returned item.Please note that the investigation is being continued in order to event (if possible) establish a root cause for the reported.

Event Description

We have been informed that the or staff was setting up the machine and could not turn it on.General anesthesia was already administered.Due to the reported event surgery was prolonged with 30 minutes.No actual patient harm occurred.

Manufacturer Narrative

In regard to this event an eva power supply was returned for investigation.Investigation of the returned power supply did not reveal any anomalies.The power supply performed within the release specification.Since the issue was solved by replacing the power supply, it is most likely that the error occurred due to an unintended use error or possibly an issue with the power supply on location.However this cannot be determined conclusively.Review of the complaint database indicated that no similar complaints have been logged on the eva surgical system subject to this complaint.Therefore, based upon the investigation performed, it was determined that the reported event cannot be attributed to a defect of the returned item or the eva surgical system subject to the event.The risk identified is included in the risk management documentation.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.No corrective or preventive actions will be implemented as a result of this incident.

Event Description

We have been informed that the or staff was setting up the machine and could not turn it on.General anesthesia was already administered.Due to the reported event surgery was prolonged with >30 minutes.No 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; zuiland, 3214V N; NL 3214VN
• MDR Report Key: 12239376
• MDR Text Key: 264128987
• Report Number: 1222074-2021-00054
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2021

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: No Information
• Device Catalogue Number: 8000.COM03
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2021
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/07/2021; 10/13/2021
• Patient Sequence Number: 1