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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI GRASPING RETRACTOR

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INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI GRASPING RETRACTOR Back to Search Results
Model Number 420278-02
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/16/2018
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 in the clevis. Missing crimp was approximately 0. 046" x 0. 032". The clevis did not exhibit any damage or wear marks. Isi has conducted a device history record (dhr) review for this device and did not find any non-conformances that were related to this reported event. 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 malfunction were to recur.
 
Event Description
It was reported that during a da vinci-assisted colostomy closure surgical procedure, a cable on the grasping retractor instrument broke. There was no report of fragment(s) falling inside the patient, patient harm, adverse outcome or injury.
 
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Brand NameENDOWRIST;DAVINCI SI
Type of DeviceGRASPING RETRACTOR
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 Key7324715
MDR Text Key102091652
Report Number2955842-2018-10046
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050369
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Patient
Type of Report Initial
Report Date 03/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number420278-02
Device Lot NumberS10100112 950
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/27/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/05/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/11/2010
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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