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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC.AESOP 3000AUTOMATED ENDOSCOPIC POSITIONING SYSTEM
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INTUITIVE SURGICAL, INC. AESOP 3000 AUTOMATED ENDOSCOPIC POSITIONING SYSTEM   Back to Search Results
Catalog Number 500-0073
Event Date 04/18/2003
Event Type  Malfunction  
Event Description

The positioner moved without command during surgery. The behavior was attributed to the user error use of incorrect headset. No adverse event was reported.

 
Manufacturer Narrative

During the conversation with the hospital staff, it was found out that the doctor was using a wireless microphone, from a vendor not approved by computer motion for use with aesop. No further evaluation of the system is expected.

 
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Brand NameAESOP 3000
Type of DeviceAUTOMATED ENDOSCOPIC POSITIONING SYSTEM
Baseline Brand NameAESOP 3000
Baseline Generic NameAUTOMATED ENDOSCOPIC POSITIONING SYSTEM
Baseline Catalogue Number500-0073
Manufacturer (Section F)
INTUITIVE SURGICAL, INC.
950 kifer road
sunnyvale CA 94086
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
950 kifer road
sunnyvale CA 94086
Manufacturer Contact
turanca orali
950 kifer road
sunnyvale , CA 94086
(805) 571 -1175
Device Event Key516261
MDR Report Key527093
Event Key500348
Report Number2029233-2004-00014
Device Sequence Number1
Product CodeGDC
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation UNKNOWN
Type of Report Initial
Report Date 02/20/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/23/2004
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number500-0073
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/18/2003
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/01/2000
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 02/23/2004 Patient Sequence Number: 1
#TreatmentTreatment Date
NA
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