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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DA VINCI V. SEALER SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

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INTUITIVE SURGICAL, INC. DA VINCI V. SEALER SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number XI
Device Problems Mechanical Problem (1384); Device Displays Incorrect Message (2591)
Patient Problem Insufficient Information (4580)
Event Date 10/27/2021
Event Type  malfunction  
Event Description
Two one time use robotic instruments malfunctioned during the same case. 1- a vessel sealer signaled a message reading "blade may be exposed". The second is a sureform 60 stapler that would not engage when inserted into the robotic arm. The rep was called and she informed them to open new instruments to complete the case. Fda safety report id # (b)(4).
 
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Brand NameDA VINCI V. SEALER
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
sunnyvale CA 94086
MDR Report Key12814134
MDR Text Key280935449
Report NumberMW5105305
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 11/09/2021
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received11/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberXI
Device Catalogue Number480422
Device Lot NumberL480422
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/09/2021
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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