MAUDE Adverse Event Report: D.O.R.C INTERNATIONAL SHIELDED TOTALVIEW ENDOILLUMINATION PROBE INCLUDING ILLUMINATED SCLERAL DEPRESSO; FIBER OPTIC ENDOILLUMINATION PROBE

Catalog Number	3269.SBS06
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history lot review: unable to perform since the lot number is unknown.Sample analysis: it was determined on 13jun2017 that an examination of the returned light fiber revealed that the coating was melted as a result of direct contact with a hot object.The damaged coating causes the fiber not to function in a proper manner.Additionally, it was identified that the damage most likely originated from the outside rather than from within the fiber itself and strengthens our observation that an external heat source was the cause.The location of the damage was found to be located somewhere halfway between the connector and the hand piece and not anywhere near the patients eye.Conclusion: the complaint has not been found acknowledged.It is unknown when this incident occurred.We are not aware of any injury that occurred.Should any further information be obtained a supplemental report will be filed.
Event or Problem Description
An initial report has been received reporting "upon arriving the office manager at the center handed me a stack of bad product." no further information was reported.The sample for this complaint has been returned and evaluated.

• Brand Name: SHIELDED TOTALVIEW ENDOILLUMINATION PROBE INCLUDING ILLUMINATED SCLERAL DEPRESSO
• Common Device Name: FIBER OPTIC ENDOILLUMINATION PROBE
• Manufacturer (Section D): D.O.R.C INTERNATIONAL; kerkweg 47e; zuidland, netherlands 3214 VC; NL 3214 VC
• MDR Report Key: 6703233
• Report Number: 1222074-2017-00005
• Device Sequence Number: 725100
• Product Code: FFS
• UDI-Device Identifier: 08717872009582
• UDI-Public: 08717872009582
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K980636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 06/13/2017

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?: Yes
• Operator of Device: Physician
• Device Catalogue Number: 3269.SBS06
• 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: 06/13/2017
• Initial Report FDA Received Date: 07/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1