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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE CAUTERY SPATUAL TIP

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INTUITIVE SURGICAL, INC NONE CAUTERY SPATUAL TIP Back to Search Results
Model Number 400160-03
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 02/01/2018
Event Type  malfunction  
Manufacturer Narrative
A review of the site's complaint history identified the cautery spatula tip accessory on this record was returned with a monopolar cautery instrument return material authorization (rma). The failure analysis (fa) evaluation and findings for the cautery spatula tip accessory have been reassessed. Fa found thermal damage on the silicone overmold and polypropylene sleeve at the distal end of the cautery tip adapter. Fa evaluation was also completed on the monopolar cautery instrument that was received at the same time. The allegation of a broken/loose cable on the instrument was unable to be reproduced. A visual inspection of the cables did not find broken or damaged cables. There was no mechanically induced physical damage found on the instrument. Since a log review cannot be performed on a disposable accessory, a log review was performed for the monopolar cautery instrument which was returned with the accessory (pn: 420142-08/s10161215-271). The following was found: per logs, the instrument was last used on (b)(6) 2018 on system (sh0158) with 15 uses remaining. However, isi was unable to confirm if the cautery spatula tip accessory was last used with the monopolar cautery instrument. Based on a reassessment of the failure analysis investigations, this complaint is a reportable event due to the following conclusion: thermal damage on the cautery spatula tip accessory is evidence of electrical discharge at a location other than intended. While there was no harm or injury to the 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
A cautery spatula tip accessory was returned to intuitive surgical, inc. (isi) with no associated return material authorization (rma)# nor complaint description. On march 01, 2018, additional information was received from the customer indicating that the instruments were returned to isi in the same box. For this particular accessory, there is no other information other than the accessory was tagged as "broken. " intuitive surgical, inc. (isi) completed customer follow and obtained the following information: the surgeon could not provide any further detail regarding the complaint. Patient-related information was requested but was unavailable.
 
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Brand NameNONE
Type of DeviceCAUTERY SPATUAL TIP
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 Key10609461
MDR Text Key209272383
Report Number2955842-2020-11003
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 Other Health Care Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 03/07/2018
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 Number400160-03
Device Catalogue Number400160
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/01/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/30/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/22/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
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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