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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC ENDOWRIST PERMANENT CAUTERY HOOK Back to Search Results
Model Number 420183-12
Device Problems Thermal Decomposition of Device (1071); Smoking (1585); Arcing (2583)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/20/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). B intuitive surgical, inc. (isi) received the permanent cautery hook (pch) instrument involved with this complaint and completed the device evaluation. Failure analysis confirmed the reported complaint. The pch instrument was found to exhibit localized melting/arcing on the monopolar yaw pulley due to a conductor wire weld breakage. Additional information related to the failure: the ear of the distal clevis was cut to inspect the damage from the reported arcing. Upon investigation, the monopolar pch instrument's conductor wire was found to be broken at the weld and found dislodged from the monopolar yaw pulley. The instrument failed electrical continuity. Visual inspection also shows the distal clevis, conductor wire cap, and idler pulley were all found to exhibit thermal damage due to the conductor wire weld damage. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. Log review shows the permanent cautery hook instrument (part # 470183-12, lot # n1170920-813) was last used on (b)(6) 2020 on system (b)(4). The instrument had 5 uses remaining. No images or videos were shared for the event. Based on the information provided, this event is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that the pch instrument had arced on hinge on the back of the hook. Furthermore, failure analysis revealed that the pch instrument was found to have a break at the weld location and subsequent thermal damage. While there was no report of any patient harm, adverse outcome or injury, recurrence of the reported failure mode could cause or contribute to an adverse event.
 
Event Description
It was reported that during a procedure, a permanent cautery hook instrument had "arc on hinge of back of hook. " there procedure was completed and there was no reported injury. Intuitive surgical, inc. (isi) followed up with the initial reporter and obtained the following additional information: this was during a procedure. There was no harm to the patient and no fragments fell into the patient. She was not able to provide any additional information about the procedure or provide any patient-related information.
 
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Brand NameENDOWRIST
Type of DevicePERMANENT CAUTERY HOOK
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 Key10556786
MDR Text Key207622328
Report Number2955842-2020-10931
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 08/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model Number420183-12
Device Catalogue Number420183
Device Lot NumberN10170920 813
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/02/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/26/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/18/2017
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: 09/18/2020 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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