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 Self-Activation or Keying (1557)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Log files log the eva system were received by d.O.R.C.Investigation will be initiated as soon as possible.

Event Description

At the end of the procedure, the surgeon used a foot pedal to activate the infusion function.Instead, the vitrectomy cutter was activated.As the surgeon did not expect the vitrector to be active, he made a single cut in the iris of the patient.The procedure was completed, however patient's harm did occur.

Manufacturer Narrative

With regard to this complaint, log files were received for investigation and the eva machine was investigated on location.Investigation revealed that the pedal swivel left setting were programmed to respond very direct.It was confirmed that when releasing the footpedal from the left position to the center position, the pedal swiveled slightly to the right and could activate the vitrectomy function.By changing the system settings, the pedal became less direct in response, which was appreciated by the surgeon.No repeat issues have been reported since.Hence, from the investigation findings it is concluded that the reported event could be attributed to an unintended use error.

Event Description

At the end of the procedure, the surgeon used a foot pedal to activate the infusion function.Instead, the vitrectomy cutter was activated.As the surgeon did not expect the vitrector to be active, he made a single cut in the iris of the patient.The procedure was completed, however patient's harm did occur.

• 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: 9874549
• MDR Text Key: 206141035
• Report Number: 1222074-2020-00024
• 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

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?: No
• Device Operator: No Information
• Device Model Number: 8000.COM02
• Device Catalogue Number: 8000.COM02
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/24/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/25/2020
• Patient Sequence Number: 1