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

Model Number 8000.COM02

Device Problem Suction Failure (4039)

Patient Problem Collapse (2416)

Event Type  malfunction  

Manufacturer Narrative

Investigation will be initiated as soon as possible.

Event Description

During a vitrectomy procedure the surgeon experienced problems with too low level of irrigation.The issue was not solved by replacing of a cartridge.The procedure was completed with a back up machine.The surgeon reported that the patient's eye collapsed twice during the surgery.However, patient harm did not occur.

Event Description

During a vitrectomy procedure the surgeon experienced problems with too low level of irrigation.The issue was not solved by replacing of a cartridge.The procedure was completed with a back up machine.The surgeon reported that the pateint's eye collapsed twice during the surgery.However, patient harm did not occur.

Manufacturer Narrative

Manufacturer's data: with regard to this event, log files were returned for investigation and an eva machine was investigated at the location.Investigation of the log files confirmed that the automatic infusion compensation was not active at the time of event.This can result in a too low irrigation pressure.However, the cause cannot be determined from analysis of the log files.In addition, the device history review could not reveal why the irrigation pressure was too low.Furthermore, no similar incidents were reported previously.Our technical specialists investigated the eva machine at the location and could not find any anomalies.All was functioning within specification.Although not required, based upon the outcome of the investigation, a minor change to height of the infusion pole was implemented as a preventive measure.Until now no similar incidents have been reported.Hence, as no clear cause can be established the result of the investigation remains inconclusive.No remedial or corrective/preventive actions are proposed as a result of this incident.Corrected data - typo for 1222074-2020-00010 was submitted today as follow-up 1 for 1222074-2020-00018.This final report is submitted as follow-up 2 to avoid the duplicate error at the esg.

Event Description

We were informed that during use of eva in combination with a lio the surgeon was hit by unfiltered laser light and noticed to have green halos in the peripheral vision.After changing the lio, the surgeon was able to complete the case.Patient harm did not occur.

Manufacturer Narrative

With regard to this complaint, only pictures from the laser indirect ophthalmoscope (lio) used at the time of the event were received for investigation.Review of these pictures revealed that the wavelength of the laser filter of the lio used is 577 nm.Hence, the lio used during the event includes an incorrect safety filter (i.E.The wavelength of the eva machine is 532 nm and the wavelength of the lio used is 577 nm) which did not protect the user from the emitted 532 nm laser light.Review of supply records indicated that the lio used during the event was not supplied by dorc.In the instruction manual of eva safety procedure regarding the use of the laser module are included and instruct the user to ensure that when using laser everyone in the room must wear appropriate eye protection suited for 532 nm.In addition, eva prompts the user to confirm that a correct filter is in place prior to be able to activate the laser.Based upon the available information it is concluded that the reported event is attributed to the user not following the manufacturer's instructions.No generic remedial or corrective/preventive actions are proposed as a result of this incident, however, the site where the event occurred was reminded to only use laser filters with 532 nm.

• Brand Name: EVA, COMBINED MACHINE INCLUDING LASER (DORC CONNECTOR)
• Type of Device: PHACOEMULSIFICATION/VITRECTOMY SYSTEM
• Manufacturer (Section D): D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA; scheijdelveqeg 2; zuiland, netherlands 3214 VN; NL 3214 VN
• MDR Report Key: 9807803
• MDR Text Key: 192766813
• Report Number: 1222074-2020-00018
• 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
• Type of Report: Initial,Followup,Followup

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 Model Number: 8000.COM02
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/09/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/29/2020; 05/29/2020
• Patient Sequence Number: 1