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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI PROGRASP FORCEPS Back to Search Results
Model Number 420093-11
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/14/2018
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. 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 suggests that if the malfunction were to recur it could cause or contribute to an adverse event.
 
Event Description
It was reported that during a da vinci-assisted surgical procedure, the surgeon could not control the instrument smoothly and the nurse found that a wire was broken on the prograsp forceps instrument. 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 DevicePROGRASP 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 Key7487082
MDR Text Key107356355
Report Number2955842-2018-10176
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeTW
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 04/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number420093-11
Device Lot NumberN10161012 986
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/06/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/13/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/11/2016
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: 05/04/2018 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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