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 Infusion or Flow Problem (2964)

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

Event Date 02/20/2024

Event Type  malfunction  

Manufacturer Narrative

The compaint is currently under investigation.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.

Event Description

We have been informed that during the vitrectomry surgery, car151 error was notified subsequently, a cartridge replacement was carried out.Also during the oil remover operation, an error occurred, leading to the operation being halted before completion.No report that actual patient harm occurred.Surgery was aborted.

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.

Event Description

We have been informed that during the vitrectomry surgery, car151 error was notified subsequently, a cartridge replacement was carried out.Also during the oil remover operation, an error occurred, leading to the operation being halted before completion.No report that actual patient harm occurred.Surgery was aborted.

• 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: 18824755
• MDR Text Key: 336803465
• Report Number: 1222074-2024-00006
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• 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
• Type of Device Usage: Reuse
• Patient Sequence Number: 1