MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. EVA NEXUS¿ COMBINED 23G TDC PACK

Catalog Number 9310.23G02

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/27/2024

Event Type  malfunction  

Manufacturer Narrative

The complaint is 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.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 viterectomy, the surgeon wanted to change the infusion line from one trocar to another trocar.At this time, the trocar valve remained in the push fit system.It was very difficult to remove the valve from the irrigation tubing and during this time there was no pressure in the eye.This happened twice during the procedure.No report that actual patient harm occurred, or that the surgery was prolonged > 30 minutes.

Event Description

We have been informed that during viterectomy, the surgeon wanted to change the infusion line from one trocar to another trocar.At this time, the trocar valve remained in the push fit system.It was very difficult to remove the valve from the irrigation tubing and during this time there was no pressure in the eye.This happened twice during the procedure.No report that actual patient harm occurred, or that the surgery was prolonged > 30 minutes.

Manufacturer Narrative

In regard to this complaint, one 23 gauge trocar set was provided for evaluation along with the video.Visual inspection revealed one cannula with closure valve attached to the infusion line with damage that possibly occurred due to removal during the surgery.Functional inspection with other cannulas from the pack did not reveal any issues.Extensive investigation could not determine the cause of the incident as there were no visible anomalies in comparison with the specifications.Device history record revealed no anomalies, and no similar complaints were reported for the affected batches prior or since the incident.As the root cause could not be determined and manufacturer related cause of the complaint could not be confirmed, no review of risk assessment was warranted.Similar complaints were chosen by selecting the same failure mode as reported, and the number of devices distributed was chosen to be number of all trocar canulla sets distributed per period.

• Brand Name: EVA NEXUS¿ COMBINED 23G TDC PACK
• Type of Device: EVA NEXUS¿ COMBINED 23G TDC PACK
• 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: 19069480
• MDR Text Key: 340020343
• Report Number: 1222074-2024-00010
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/09/2024

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 Catalogue Number: 9310.23G02
• Device Lot Number: 21178-*-*-1
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/09/2024
• Type of Device Usage: Initial
• Patient Sequence Number: 1