MAUDE Adverse Event Report: D.O.R.C INTERNATIONAL ILLUMINATED STEPPED LASER PROBE, CURVED WITH TAPERED TIP; OPHTHALMIC LASER SYSTEM BEAM GUIDE

Model Number	7510.ALC
Medical Device Problem Code	Environmental Particulates (2930)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The following incident has been reported.A 23ga curved illumination probe was defective.Smoking at the tip.There was no patient injury.There was no user injury.The smoking was noticed in the eye.The case was completed with a new separate dorc probe without further incident.The sample is available for an evaluation.
Additional Manufacturer Narrative
A call was placed to the reporter of this event for additional information.It is known that smoking is not uncommon and is likely due to tissue, blood, or debris on the tip.The probe is so tiny and if it touches blood or makes contact with blood or tissue will smoke.This device is intended to be used in conjunction with ophthalmic laser system during surgery to invasively direct and deliver laser energy to treat non-refractive conditions like a retinal tear.The laser is not intended to be destructive.It is likely that the device started out working and at some point either made contact with blood or tissue.Investigation of the concerned product revealed that there was no device malfunction.Examination of the returned sample revealed foreign material on the tip.The foreign material observed is most likely blood residue or tissue.The presence of the material will cause smoke as a result of when the laser is in use.Smoke is generated from the end of the laser probe as the result of the combination of heat and tissue/blood residue and is a common phenomenon and not considered a device malfunction or failure.Additional information will be provided by a supplemental report.
Additional Manufacturer Narrative
Conclusion: examination of the returned product revealed foreign material on the tip.The foreign material observed is most likely blood residue or tissue.The presence of the material will cause smoke as a result of heat when the laser is in use.Since the particles are very small, they are not likely to cause any patient harm.Please note that complaints regarding dorc product will continue to be monitored by qa.At this time we have determined this complaint is not confirmed.This complaint has now been closed.Should any further information be reported a supplemental will be filed.

• Brand Name: ILLUMINATED STEPPED LASER PROBE, CURVED WITH TAPERED TIP
• Common Device Name: OPHTHALMIC LASER SYSTEM BEAM GUIDE
• Manufacturer (Section D): D.O.R.C INTERNATIONAL; scheijdelveweg 2; zuidland, netherlands 3214 VN; NL 3214 VN
• MDR Report Key: 6773404
• Report Number: 1222074-2017-00006
• Device Sequence Number: 136710
• Product Code: HQF
• UDI-Device Identifier: 08717872016122
• UDI-Public: 08717872016122
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K031023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: 7510.ALC
• Device Catalogue Number: 7510.ALC
• 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: 07/27/2017
• Supplement Date Received by Manufacturer: 11/01/2017; 11/04/2017
• Initial Report FDA Received Date: 08/08/2017
• Supplement Report FDA Received Date: 11/01/2017; 11/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1