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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI TENACULUM FORCEPS

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INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI TENACULUM FORCEPS Back to Search Results
Model Number 420207-07
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/20/2018
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) has 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 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 during a da vinci-assisted myomectomy procedure, a ¿wire¿ from the tenaculum forceps instrument was broken. The planned surgical procedure was completed and no patient harm, adverse outcome or injury was reported. There were no reports of any fragment(s) falling inside the patient.
 
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Brand NameENDOWRIST;DAVINCI SI
Type of DeviceTENACULUM FORCEPS
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 Key7600554
MDR Text Key111019253
Report Number2955842-2018-10285
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeKR
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 05/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number420207-07
Device Lot NumberN10171025 367
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/11/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/17/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/23/2017
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: 06/14/2018 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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