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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST LARGE NEEDLE DRIVER

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INTUITIVE SURGICAL, INC ENDOWRIST LARGE NEEDLE DRIVER Back to Search Results
Model Number 420006-08
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/15/2018
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the instrument involved with this complaint and completed the device evaluation. Failure analysis investigation was able to confirm the reported issue. The instrument was found to have a broken pitch cable at the distal clevis hub. The broken cable segment that contained the crimp was missing from the clevis. A device history record (dhr) review for this device was conducted and did not find any non-conformances that would affect any material of the final product and/or the quality or performance of the instrument. The customer reported complaint does not itself constitute an mdr reportable event; however, the broken pitch cable found during failure analysis could cause or contribute to an adverse event if the failure mode were to recur.
 
Event Description
It was reported that prior to the start of a da vinci-assisted adrenalectomy procedure, the large needle driver instrument was noted to have a damaged cable which led to inadequate movement. The instrument was not used in the procedure. The procedure was completed with no report of patient harm, adverse outcome or injury.
 
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Brand NameENDOWRIST LARGE NEEDLE DRIVER
Type of DeviceLARGE NEEDLE DRIVER
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 Key7644212
MDR Text Key112566349
Report Number2955842-2018-10330
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K050369
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 06/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number420006-08
Device Lot NumberN13160726 823
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/12/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/25/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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