MAUDE Adverse Event Report: D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV DMEK SINSKEY HOOK UP

Catalog Number 50.2201

Device Problem Material Separation (1562)

Patient Problem Intraocular Pressure, Delayed, Uncontrolled (1936)

Event Date 11/27/2014

Event Type  Injury  

Manufacturer Narrative

We have investigated the instrument.The tip of the instrument is broken.It is unknown when or where the tip broke, if during use or during transport we shall not know.No further information on the outcome of the patient.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)(4) during a tele-conference on 05/31/2017.This event was reported due to an event of hypotony.Assuming worst case during surgery, air bubbles observed at the probe.This may cause injury to the patient.Hence it is reportable.The risk is possible injury by microbial, viral or prion infection (patient harm) all available information has been disclosed.This complaint is now closed.

Event Description

A report was received of an event that occurred in (b)(6).The following event was reported : "it seems there is a little hole (valve) in the tube which is connecting the handpiece.Our client thinks it should'nt be there because the anterior chamber collapsed twice.".

• Brand Name: DMEK SINSKEY HOOK UP
• Type of Device: DMEK SINSKEY HOOK UP
• Manufacturer (Section D): D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV; scheijdelveweg 2; zuidland, netherlands 3214 VN; NL 3214 VN
• Manufacturer (Section G): D.O.R.C DUTCH OPHTHALMIC 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: 7286282
• MDR Text Key: 100640045
• Report Number: 1222074-2018-00041
• Device Sequence Number: 1
• Product Code: HNQ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 11/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 50.2201
• Device Lot Number: 2000362383
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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