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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CAMERA CONTROL UNIT, HIGH DEF, 560P LIGHT SOURCE, ENDOSCOPE, XENON ARC

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SMITH & NEPHEW, INC. CAMERA CONTROL UNIT, HIGH DEF, 560P LIGHT SOURCE, ENDOSCOPE, XENON ARC Back to Search Results
Model Number 72201919
Device Problem Smoking (1585)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The device was received for evaluation. There was a relationship found between the returned device and the reported incident. A visual inspection was performed on the product and no issue was observed. Complaint of smoke and burnt odor was caused by a large capacitor on the power supply which split open and emitted a resinous material when unit overheated. Ccu still passes functional testing and 6 hour burn-in but the power supply needs to be replaced. A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.
 
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that the device had a burning smell and smoke comingout. There was no delay or patient injury reported.
 
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Brand NameCAMERA CONTROL UNIT, HIGH DEF, 560P
Type of DeviceLIGHT SOURCE, ENDOSCOPE, XENON ARC
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
Manufacturer (Section G)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
Manufacturer Contact
jim gonzales
7000 west william cannon drive
austin, TX 78735
MDR Report Key7263131
MDR Text Key135423715
Report Number1643264-2018-00125
Device Sequence Number1
Product Code GCT
Combination Product (y/n)N
PMA/PMN Number
K070266
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72201919
Device Catalogue Number72201919
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/21/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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