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

Catalog Number 8000.COM04

Device Problems Failure to Cut (2587); No Pressure (2994)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

A visual inspection of the returned device found that the guarantee seals of the module had been broken open.Timing of the opening of the module is unclear.When the returned module was tested it could immediately be observed that the valve set did not work properly and the cutter did not work.Further analysis determined that the white valve was not working properly.The cause of this was that the valve was stuck by dirt.The valve was therefore not responding and no air was coming out of connector.It should be noted that in accordance with the instruction manual the user must not do any maintenance, or calibration of the eva that require an opening of the device.All maintenance activities that require opening of the protective housing have to be done by service personnel that has been trained and authorized by d.O.R.C.International.Based upon the fact that timing of the opening of the module is unclear the origin and timing of the dirt accumulation can not be determined.Dorc will continue to monitor the safety of its devices on the market.

Event Description

Cutter stop working without any error msg, cutting sound (tik tik tik) is coming from the vitrectomy module but air pressure (responsible to drive the cutter) is not coming out from the module seem like some blockage in the module.Surgery had to be aborted due to this event.

• Brand Name: EVA
• Type of Device: PHACOEMULSIFICATION/VITRECTOMY SYSTEM
• Manufacturer (Section D): D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA; scheijdelveqeg 2; zuiland, 3214 VN; NL 3214 VN
• Manufacturer (Section G): D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA; scheijdelveqeg 2; zuiland, 3214 VN; NL 3214 VN
• Manufacturer Contact: chris fryer ; scheijdelveqeg 2; zuiland, 3214 -VN ; NL 3214 VN
• MDR Report Key: 9631856
• MDR Text Key: 197298617
• Report Number: 1222074-2020-00007
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 8000.COM04
• Type of Device Usage: N
• Patient Sequence Number: 1