MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. EVA, COMBINED MACHINE NCBF INCLUDING LASER (DORC CONNECTOR); PHACOEMULSIFICATION/VITRECTOMY SYSTEM

Catalog Number 8000.COM05

Device Problem Output below Specifications (3004)

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

Event Date 04/05/2023

Event Type  malfunction  

Manufacturer Narrative

In case of a product return, the device will be investigated, otherwise we will review the device history record, and/or any log files if available, or try to replicate the problem on similar product.As investigations on the actual product or representative sample of a batch may alter the device, we request to inform us within 7 days after submission of this report, in case the investigations that alter the device should be halted until approval of the nca, as per article 89 of eu-mdr.

Event Description

We have been informed that during phaco procedure, while anesthesia was administered and incisions were made, it was noticed that the suction of the phaco handpiece did not work.Unable to solve the issue, it was decided to abort surgery and reschedule it to the next day.No report that actual patient harm occurred.

Event Description

We have been informed that during phaco procedure, while anesthesia was administered and incisions were made, it was noticed that the suction of the phaco handpiece did not work.Unable to solve the issue, it was decided to abort surgery and reschedule it to the next day.No report that actual patient harm occurred.

Manufacturer Narrative

Review of the logfiles at the date of the reported event revealed some error messages but could not confirm the occurrence of the reported pum71.This error message is a clamping error which occurs when the minimum vacuum pressure for clamping is not reached within a set time.Unfortunately, the complaint cannot be further investigated nor confirmed as nothing was returned to d.O.R.C for investigation.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 (pd-defect-).Since 2020 more than (b)(4) surgeries have been performed with the eva surgical systems installed.Please note that the failure code pd-defect- will not always lead to a prolonged/delayed surgery.Please note that while the 2023 incident numbers are up to date, the 2023 installed base figures are from (b)(6) 2023.As in general the installed base increases, the actual number of devices in the market most likely is slightly higher.

Event Description

We have been informed that during phaco procedure, while anesthesia was administered and incisions were made, it was noticed that the suction of the phaco handpiece did not work.Unable to solve the issue, it was decided to abort surgery and reschedule it to the next day.No report that actual patient harm occurred.

Manufacturer Narrative

The device will be returned but is not accessible for investigation yet.The investigation will be continued when the device is available for examination.

• Brand Name: EVA, COMBINED MACHINE NCBF INCLUDING LASER (DORC CONNECTOR)
• 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: petra holland ; scheijdelveweg 2; zuidland, 3214 -VN ; NL 3214 VN
• MDR Report Key: 16761462
• MDR Text Key: 313502075
• Report Number: 1222074-2023-00039
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• 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
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1