MAUDE Adverse Event Report: DUTCH OPHTHALMIC USA ILLUMINATED STEPPED LASERPROBE, 23G / 0.6 M WITH ALCON® CONNECTOR; ILLUMINATED LASER PROBE

Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history lot review: the lot is unknown.Sample analysis: no sample was returned for an evaluation.It was reported it was sent back to us, however has not been received.Conclusion: the reported complaint is not confirmed.At this time, this complaint is closed.The report was filed as an adverse event by the user facility and the facility has not provided any information that a patient had an other serious important medical event.Therefore am submitting this as a correction to the initial report filed by the user facility.
Event or Problem Description
We received a medwatch report 1222074-2017-00001.A box was checked off of an adverse event.The user facility has been contacted for follow up information.It has been learned this was not an adverse event.The reporter clarified that the incident was detected prior to surgery when setting up the machine the light turned on alerting that is was not detecting the probe.The device was not used.They used alternative devices for the surgery without further incident.There is no sample to evaluate.

• Brand Name: ILLUMINATED STEPPED LASERPROBE, 23G / 0.6 M WITH ALCON® CONNECTOR
• Common Device Name: ILLUMINATED LASER PROBE
• Manufacturer (Section D): DUTCH OPHTHALMIC USA; 10 continential dr; exeter NH 03853
• MDR Report Key: 6677806
• Report Number: 1222074-2017-00002
• Device Sequence Number: 16636806
• Product Code: HQF
• UDI-Device Identifier: 08717872016122
• UDI-Public: 08717872016122
• Combination Product (Y/N): N
• PMA/510(K) Number: K031023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/14/2017

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?: No
• Operator of Device: Physician
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2017
• Initial Report FDA Received Date: 06/29/2017
• Patient Sequence Number: 1