MAUDE Adverse Event Report: D.O.R.C INTERNATIONAL EVA, COMBINED MACHINE INCLUDING LASER (DORC CONNECTOR); PHACOEMULSION VITRECTOMY SYSTEM

Model Number 8000.COM02

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/13/2014

Event Type  malfunction  

Manufacturer Narrative

The rca can not be found on this foot pedal.In (b)(6) 2015, 14 pedals were examined, but whether this pedal was one of these pedals is unclear.The rca of these studies have been stored.This has already been investigated and after an upgrade (flash).A new foot pedal has been provided to this facility.This reportable event was identified during a voluntary retrospective review of all complaints since 2015 by the manufacturer (dutch ophthalmic research centre b.V.).Details of this activity were discussed with cdrh office of compliance (b)(6)) during a tele-conference on (b)(6) 2017.All available information has been provided.This complaint has now been closed.

Event Description

A report has been received of an event that occurred in ireland.The footpedal of eva is not working at all.There is no report of patient injury.It is unknown when the incident occurred.

• Brand Name: EVA, COMBINED MACHINE INCLUDING LASER (DORC CONNECTOR)
• Type of Device: PHACOEMULSION VITRECTOMY SYSTEM
• Manufacturer (Section D): D.O.R.C INTERNATIONAL; scheijdelveweg 2; zuidland, netherlands 3214 VN; NL 3214 VN
• Manufacturer (Section G): D.O.R.C INTERNATIONAL BV; scheijdelveweg 2; zuidland, netherlands 3214 VN; NL 3214 VN
• Manufacturer Contact: laura smith ; 10 continental dr; exeter, NH 03833 ; 6037538824
• MDR Report Key: 7217807
• MDR Text Key: 98197778
• Report Number: 1222074-2018-00007
• Device Sequence Number: 1
• Product Code: HQF
• UDI-Device Identifier: 08717872019659
• UDI-Public: 08717872019659
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K142877
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 8000.COM02
• Device Catalogue Number: 8000.COM02
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1