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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI PERMANENT CAUTERY SPATULA

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INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI PERMANENT CAUTERY SPATULA Back to Search Results
Model Number 420184-11
Device Problems Thermal Decomposition of Device (1071); Melted (1385)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 05/15/2018
Event Type  malfunction  
Manufacturer Narrative
On 6/14/2020, intuitive surgical, inc. (isi) completed its evaluation of the permanent cautery spatula instrument. Failure analysis (fa) confirmed the customer reported issue as the instrument was found to have thermal damage on the distal clevis. Fa removed the clevis ear and no conductor wire insulation damage or broken conductor wire was observed at the weld. The instrument passed the electrical continuity test and was found to have 2 lives remaining based on the logs. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. A log review was performed for the permanent cautery spatula reported in this complaint (pn: (b)(4)) and the following was found: per logs, the instrument was last used on (b)(6) 2020 on system sh2073, with 2 uses remaining. The permanent cautery spatula instrument allegedly ¿short circuited¿ (i. E. Potentially arced) with no evidence or claim of user mishandling or misuse. This complaint is being reported because there was evidence of thermal damage on the distal clevis. Thermal damage on the distal clevis is evidence of electrical discharge at a location other than intended. While there was no harm or injury to patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur. This report has been generated in response to fda inspectional observations dated 06-mar-2020.
 
Event Description
It was reported that during a da vinci-assisted wedge resection procedure, performed on (b)(6) 2018, there was a "short circuit" with the permanent cautery spatula (pcs) instrument. The surgical staff completed the procedure and there was no reported patient injury. Intuitive surgical, inc. (isi) completed customer follow-up and obtained the following information: the customer is unable to provide any additional narrative regarding the event. The customer indicated that the surgical staff routinely checks instruments prior to insertion and checks cannulas with the gage pins. Additional patient-related information was also requested, but was unavailable.
 
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Brand NameENDOWRIST;DAVINCI SI
Type of DevicePERMANENT CAUTERY SPATULA
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA 95051
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA 95051
Manufacturer Contact
david wang
3410 central expressway
santa clara, CA 95051
4085232100
MDR Report Key10609467
MDR Text Key209272943
Report Number2955842-2020-11002
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 Non-Healthcare Professional
Remedial Action Other
Type of Report Initial
Report Date 05/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number420184-11
Device Catalogue Number420184
Device Lot NumberN10161026 213
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/25/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/25/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 09/30/2020 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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