MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER BV DISP 23G TROCAR SYSTEM, STERIL

Catalog Number 1272.EDPP6

Device Problem Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2018

Event Type  malfunction  

Manufacturer Narrative

Found foreign particle in cannula tip, there is a possibility of using the cannula, hence concluded as reportable.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 (b)(6) 2017.All available information has been disclosed.This complaint has now been closed.

Event Description

A report from (b)(6) has been received.The following has been reported: a piece of plastic (probably from the production process) at the tip of the trocar.The customer gave the particle to his microbiology.No further information.All information has been disclosed.

• Brand Name: DISP 23G TROCAR SYSTEM, STERIL
• Type of Device: DISP 23G TROCAR SYSTEM, STERIL
• 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: 7430800
• MDR Text Key: 105900128
• Report Number: 1222074-2018-00072
• Device Sequence Number: 1
• Product Code: NGY
• UDI-Device Identifier: 08717872002415
• UDI-Public: 08717872002415
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 1272.EDPP6
• Device Lot Number: 2000365241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/10/2015
• Initial Date FDA Received: 04/13/2018
• 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