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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 04/04/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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 broke cable segment that contains the crimp was missing from clevis. 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 surgical procedure, the tenaculum forceps had a "loose wheel". 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 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 Key7505032
MDR Text Key108292618
Report Number2955842-2018-10199
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
Type of Report Initial
Report Date 05/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number420207-07
Device Lot NumberN10170406
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/25/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/02/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/05/2017
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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