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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DUTCH OPHTHALMIC SHEILDED TOTALVIEW ENDOILLUMINATION PROBE

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DUTCH OPHTHALMIC SHEILDED TOTALVIEW ENDOILLUMINATION PROBE Back to Search Results
Catalog Number 3269.SBS06
Device Problem Device Issue (2379)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/14/2017
Event Type  malfunction  
Manufacturer Narrative
The device underwent an investigation and is now complete on the light fiber product 3269. Sbs06, lot 1905129 reported and returned to us. The device history lot review: the lot meet the specification outlined for release. We have not received any similar complaints on this lot. We have not received any information of same or similar like events that pertain to this lot or on any other lot of this same or similar manufactured product. Sample analysis: it was detected that the outside of the fiber was melted. This fiber component was produced at a different manufacturer. It is unknown how this occurred. It is possible that the gladding of the fiber was damaged during production, therefore heat was able to build up. Conclusion: the lot reported meets the specification outlined for release and is considered an isolated incident. Please note that should any further information be received, we will submit a supplemental report.
 
Event Description
A report has been received reporting that the probe had started smoking. A call was placed to user facility for additional information. It was reported the incident occurred during surgery while idle but connected to the light source. No injury occurred.
 
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Brand NameSHEILDED TOTALVIEW ENDOILLUMINATION PROBE
Type of DeviceILLUMINATION PROBE
Manufacturer (Section D)
DUTCH OPHTHALMIC
10 continental dr
exeter NH 03833
Manufacturer (Section G)
DUTCH OPHTHALMIC USA
10 continental dr
exeter NH 03833
Manufacturer Contact
laura smith
10 continental dr
exeter, NH 03853
6037786929
MDR Report Key6482040
MDR Text Key72790027
Report Number1222074-2017-00001
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 user facility
Reporter Occupation
Type of Report Initial
Report Date 03/16/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/01/2021
Device Catalogue Number3269.SBS06
Device Lot Number1905129
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/28/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/19/2016
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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