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U.S. Department of Health and Human Services

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

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D.O.R.C INTERNATIONAL SHIELDED TOTALVIEW ENDOILLUMINATION PROBE INCLUDING ILLUMINATED SCLERAL DEPRESSO FIBER OPTIC ENDOILLUMINATION PROBE Back to Search Results
Catalog Number 3269.SBS06
Device Problem No Device Output (1435)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/12/2016
Event Type  malfunction  
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 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.
 
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Brand NameSHIELDED TOTALVIEW ENDOILLUMINATION PROBE INCLUDING ILLUMINATED SCLERAL DEPRESSO
Type of DeviceFIBER OPTIC ENDOILLUMINATION PROBE
Manufacturer (Section D)
D.O.R.C INTERNATIONAL
kerkweg 47e
zuidland, netherlands 3214 VC
NL 3214 VC
Manufacturer (Section G)
DUTCH OPHTHALMIC USA
10 continental dr
exeter NH 03833
Manufacturer Contact
laura smith
10 continental dr
exeter, NH 03833
6037786929
MDR Report Key6703233
MDR Text Key79911880
Report Number1222074-2017-00005
Device Sequence Number1
Product Code FFS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K980636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 06/13/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number3269.SBS06
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/13/2017
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

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