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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI XI TIP-UP FENESTRATED GRASPER

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INTUITIVE SURGICAL, INC DA VINCI XI TIP-UP FENESTRATED GRASPER Back to Search Results
Model Number 470347-09
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/21/2018
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the instrument involved with this complaint and completed the device evaluation. Failure analysis confirmed the customer reported failure. The instrument was found to have a broken pitch cable at the distal clevis hub. The broken cable segment that contains the crimp was missing from clevis. The clevis did not exhibit any damage or wear marks. Other cables at the wrist were not damaged. A device history record (dhr) review for the device involved with the complaint has been completed. No non-conformances were identified to be related to this complaint.
 
Event Description
It was reported that during central processing, the customer noted a broken cable on the tip up fenestrated grasper instrument. There was no report of patient involvement.
 
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Brand NameDA VINCI XI
Type of DeviceTIP-UP FENESTRATED GRASPER
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
950 kifer rd.
sunnyvale
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
950 kifer rd.
sunnyvale
Manufacturer Contact
tabitha reed
950 kifer rd.
sunnyvale 
4085232100
MDR Report Key7478732
MDR Text Key107082723
Report Number2955842-2018-10169
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 04/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470347-09
Device Lot NumberN10180119 0039
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/29/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/05/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/18/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 05/02/2018 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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