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 Communication or Transmission Problem (2896)

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

Event Date 03/30/2023

Event Type  malfunction  

Event Description

We have been informed that during surgery, the battery of the foot switch jumped from 83% to 0%.The user tried to connect the foot switch with cables to the machine but this did not help.A backup machine was used in exchange in order to complete the procedure.No report that actual harm occurred, however due to the reported event surgery was prolonged > 30 minutes.

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.

Manufacturer Narrative

In regard to this complaint, a main pedal was provided for investigation.The complaint could not be reproduced during investigation, the pedal worked according to d.O.R.C specifications.Since no issues were detected during testing, it was concluded that the reported complaint cannot be attributed to the main pedal that was provided for investigation.The risk identified is included in the risk management documentation.Trend analysis indicates that the product is performing within anticipated rates.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 (fp-defect-*).Since 2020 more than 850.000 surgeries have been performed with the eva surgical systems installed.Please note that the failure code fp-defect-* will not always lead to a prolonged surgery.

Event Description

We have been informed that during surgery, the battery of the foot switch jumped from 83% to 0%.The user tried to connect the foot switch with cables to the machine but this did not help.A backup machine was used in exchange in order to complete the procedure.No report that actual harm occurred, however due to the reported event surgery was prolonged > 30 minutes.

• 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: 16730362
• MDR Text Key: 313710517
• Report Number: 1222074-2023-00037
• 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
• Report Date: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• 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