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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. PK DISSECTING FORCEP SI / S PK DISSECTING FORCEP

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INTUITIVE SURGICAL, INC. PK DISSECTING FORCEP SI / S PK DISSECTING FORCEP Back to Search Results
Model Number DA VINCI SI
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Information (3190)
Event Date 08/12/2016
Event Type  malfunction  
Event Description
Broken conductor wire at the yaw pulley exit. The wire detached from it's connection at the grip due to insulation material breaking from distal end of instrument. This failure has been a common issue with this and other energy instruments. Failure at same place on 3 different instruments. Insulation material used on this device continues to break off in the same location. Other energy instruments also manufactured by this company are failing at the same location as this particular instrument. Mfg # 420227-06.
 
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Brand NamePK DISSECTING FORCEP
Type of DeviceSI / S PK DISSECTING FORCEP
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
950 kifer road
sunnyvale CA 94086
MDR Report Key6983223
MDR Text Key90579078
Report NumberMW5072982
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 Other Caregivers
Type of Report Initial
Report Date 09/11/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDA VINCI SI
Device Catalogue Number420227-06
Device Lot NumberN10160304-385
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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