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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUTIVE SURGICAL DA VINCI S ROBOTIC HANDPIECE, PERMINENT CAUTERY HOOK

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INTUTIVE SURGICAL DA VINCI S ROBOTIC HANDPIECE, PERMINENT CAUTERY HOOK Back to Search Results
Catalog Number 420183
Device Problems Material Separation (1562); Malposition of Device (2616)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/20/2019
Event Type  malfunction  
Event Description
During procedure using robotic permanent cautery hook, the handpiece experienced failure in the cautery hook holding trunnions on the hand piece. The trunnions separated from the handpiece which caused the cautery hook to not position correctly for cautery. The handpiece was retracted and disconnected from the robotic surgical system. Case proceeded without incident.
 
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Brand NameDA VINCI S
Type of DeviceROBOTIC HANDPIECE, PERMINENT CAUTERY HOOK
Manufacturer (Section D)
INTUTIVE SURGICAL
1266 kifer road
sunnyvale CA 94086
MDR Report Key9161200
MDR Text Key161373741
Report Number9161200
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 09/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number420183
Device Lot NumberN10181025142
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/21/2019
Event Location Hospital
Date Report to Manufacturer10/07/2019
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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