MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER BV EVA CARTRIDGE WITH 0.5 L COLLECTION BAG

Catalog Number 8100.CAR1

Device Problems Inability to Irrigate (1337); Material Twisted/Bent (2981)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 05/03/2017

Event Type  Injury  

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)(4)).Details of this activity were discussed with cdrh office of compliance ((b)(6)) during a tele-conference on 05/31/"201" during surgery, the blue irrigation line twisted itself and stopped irrigation.Caused hypotony, a serious harm, hence concluded as reportable.All available information has been disclosed.This complaint has now been closed.

Event Description

Problem description: during surgery, the blue irrigation line twisted itself and stopped irrigation.Further the eye went really soft.

• Brand Name: EVA CARTRIDGE WITH 0.5 L COLLECTION BAG
• Type of Device: EVA CARTRIDGE WITH 0.5 L COLLECTION BAG
• 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: 7682728
• MDR Text Key: 113813882
• Report Number: 1222074-2018-00240
• Device Sequence Number: 1
• Product Code: HQE
• UDI-Device Identifier: 08717872019178
• UDI-Public: 08717872019178
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K142877
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 05/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 8100.CAR1
• Device Lot Number: 2000385594
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/03/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other