MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER BV DIRECTIONAL LASER PROBE WITH DORC CONNECTOR.(25 GAUGE / 0.5 MM)

Catalog Number	7225.DORC
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation showed that the fiber inside de outer shell is broken.Where this has occurred could not be determined by the investigation.The outer cover of the fiber was still intact.No coherent light was able to reach the operator, however, during the retrospective review, a broken cable if laser probe and surgeon looked it without safety goggles and felt dazzled.Hence reportable.This reportable event was identified during a voluntary retrospective review of all complaints since 2015 by the manufacturer ((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.The complaint is not confirmed.This complaint has now been closed.
Event or Problem Description
Laser probe damaged on the middle of the cable/fiber.Looked at it without safety goggles.Normally i look through the microscope with filter, but as it did not came/appeared any laser effects i looked to the side.The next day i felt blinded/dazzled.Pretty serious i think.There is no further information on the health status.Sample is available.

• Brand Name: DIRECTIONAL LASER PROBE WITH DORC CONNECTOR.(25 GAUGE / 0.5 MM)
• Common Device Name: DIRECTIONAL LASER PROBE WITH DORC CONNECTOR.(25 GAUGE / 0.5 MM)
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• MDR Report Key: 7544617
• Report Number: 1222074-2018-00156
• Device Sequence Number: 13485493
• Product Code: HQF
• UDI-Device Identifier: 08717872008578
• UDI-Public: 08717872008578
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 02/22/2016

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
• Operator of Device: Physician
• Device Catalogue Number: 7225.DORC
• Device Lot Number: 2000375384
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2016
• Initial Report FDA Received Date: 05/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1