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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC ENDOWRIST PERMANENT CAUTERY SPATULA Back to Search Results
Model Number 470184-12
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 04/13/2020
Event Type  malfunction  
Manufacturer Narrative
The failure analysis evaluation and findings for the permanent cautery spatula have been reassessed. Failure analysis (fa) confirmed the customer reported issue as the permanent cautery spatula instrument was found to have thermal damage on the monopolar yaw pulley and distal clevis. Fa noted black char marks were present at the distal end and concluded any material missing from the damage of the yaw pulley was likely thermally inducted rather than mechanically induced. Fa removed one side of the distal clevis ear and the silicone potting did not appear compromised. The instrument conductor was not damaged around the weld location and passed an electrical continuity test. 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 (sk2760) with 3 uses remaining. This complaint is being reported because there was evidence of thermal damage on the distal clevis and monopolar yaw pulley. Thermal damage on the distal clevis and monopolar yaw pulley 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
The permanent cautery spatula was identified in central processing to have a dark spot near the tip. The site noted that they could not clean the spot by washing. Intuitive surgical, inc. (isi) completed customer follow-up, but the customer could not provide any additional narrative regarding the complaint. Patient-related information was also requested, but was unavailable.
 
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Brand NameENDOWRIST
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 Key10609839
MDR Text Key209273734
Report Number2955842-2020-11021
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131861
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
Report Date 05/09/2020
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 Number470184-12
Device Catalogue Number470184
Device Lot NumberN10180222 0042
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/07/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/09/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/21/2018
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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