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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY AMERICA INC AIDA SCB DVD-M ENDOSCOPIC CAMERA

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KARL STORZ ENDOSCOPY AMERICA INC AIDA SCB DVD-M ENDOSCOPIC CAMERA Back to Search Results
Model Number 292945 29
Device Problems Failure to Power Up (1476); Data Problem (3196)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/24/2012
Event Type  malfunction  
Event Description
Endoscopic camera failed to turn on during case; unable to store data.
 
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Brand NameAIDA SCB DVD-M
Type of DeviceENDOSCOPIC CAMERA
Manufacturer (Section D)
KARL STORZ ENDOSCOPY AMERICA INC
2151 e. grand avenue
el segundo CA 90245
MDR Report Key5346405
MDR Text Key35159249
Report Number5346405
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 12/11/2015
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/06/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number292945 29
Other Device ID NumberCONTROL # 45144
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/11/2015
Event Location Hospital
Date Report to Manufacturer12/11/2015
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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