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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. LARGE CLIP APPLIER SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

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INTUITIVE SURGICAL, INC. LARGE CLIP APPLIER SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number VER: 12
Device Problem Failure to Sense (1559)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
Clip applier was inserted onto robot arm and it was "not detected". Fda safety report id # (b)(4).
 
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Brand NameLARGE CLIP APPLIER
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
MDR Report Key13011159
MDR Text Key282359411
Report NumberMW5106046
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberVER: 12
Device Lot NumberN10190504 0054
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Is This a Reprocessed and Reused Single-Use Device? No

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