MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER BV EVA, COMBINED MACHINE INCLUDING LASER (SMA CONNECTOR)

Model Number 8000.COM03

Device Problem Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2017

Event Type  malfunction  

Manufacturer Narrative

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).Incident occurred during surgery, low voltage of main foot pedal and unable to proceed with surgery which may lead to patient injury, hence concluded as reportable.This may lead to a prolonged delay.All available information has been disclosed.This complaint has now been closed.

Event Description

Low voltage on foot pedal, cannot clear message and unable to proceed with procedure.Pedal does not work wirelessly nor hardwired.New pedal and cables requested.

• Brand Name: EVA, COMBINED MACHINE INCLUDING LASER (SMA CONNECTOR)
• Type of Device: EVA, COMBINED MACHINE INCLUDING LASER (SMA CONNECTOR)
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• Manufacturer (Section G): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• Manufacturer Contact: laura smith ; 10 continental dr; bldg 1; exeter, NH 03833 ; 6037786929
• MDR Report Key: 7664982
• MDR Text Key: 113299281
• Report Number: 1222074-2018-00225
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 08717872019659
• UDI-Public: 08717872019659
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142877
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 02/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 8000.COM03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1