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

Catalog Number 8000.COM05

Device Problems Collapse (1099); Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 02/16/2021

Event Type  malfunction  

Manufacturer Narrative

The reported event is under investigation.

Event Description

We were informed that before surgery began, the infusion line was not filled with bss.This was solved by performing a second priming routine.Before the line was inserted into the trocar, bss dripped out of the tip.It was reported that during the surgery the eyeball collapsed.The eva was restarted after that no other issues were encountered.No actual patient harm or delay was reported.

Manufacturer Narrative

With regard to the reported event no product was returned for investigations, only logfiles were provided for review.Review of the logfiles revealed one error message indicating that the height of the infusion bottle and tubing connections should be checked.After the occurrence of the error message, the issue was solved with a restart of the eva surgical system.The error did not reoccur.Review of the complaint database indicated that no similar complaints have been logged on the eva surgical system subject to this complaint until today.Also a dhr review did not reveal any anomalies.Based on the information available, it was determined that the reported event cannot be attributed to the eva surgical system subject to this event.It is possible that this event occurred due to an unintended use error, however this cannot be determined conclusively.

Event Description

We were informed that before surgery began, the infusion line was not filled with bss.This was solved by performing a second priming routine.Before the line was inserted into the trocar, bss dripped out of the tip.It was reported that during the surgery the eyeball collapsed.The eva was restarted after that no other issues were encountered.No actual patient harm or delay was reported.

• Brand Name: EVA
• Type of Device: PHACOEMULSIFICATION/VITRECTOMY SYSTEM
• Manufacturer (Section D): D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.; scheijdelveweg 2; zuidland, nl 3214 VN; NL 3214 VN
• MDR Report Key: 11487113
• MDR Text Key: 243115440
• Report Number: 1222074-2021-00011
• 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: foreign
• Type of Report: Initial,Followup
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 8000.COM05
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/30/2021
• Patient Sequence Number: 1