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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 470183-14
Device Problems Break (1069); Failure to Deliver Energy (1211)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/11/2021
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the instrument involved with this complaint and completed the device evaluation. Failure analysis investigations replicated and confirmed the customer reported complaint "energy wasn't activated". Failure analysis found the primary failure of broken conductor wire at the proximal end to be related to the customer reported complaint. The instrument was found to have a broken conductor wire at the proximal end. The location of the break is where the conductor wire meets the connector pin. The instrument failed the electrical continuity test. No signs of thermal damage were observed. The root cause of this failure is attributed to manufacturing. A review of the device logs for the permanent cautery hook (part# 470183-14 | lot/serial# n10210104-0064) associated with this event has been performed. Per this review of the logs, the permanent cautery hook was last used on (b)(6) 2021 via system serial# (b)(4). There were 9 uses remaining after this last usage. This last usage of the device per the log review matches the reported event date, indicating that the instrument was not used after the date of the reported event. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. No image or video clip for the reported event was available for review. A system log review was performed, but no errors related to this event would exist in the logs. Based on the information provided at this time, this complaint is being reported because the bipolar instrument had conductor wire damage with no evidence or claim of user mishandling or misuse. While there was no harm or injury to the patient, the reported failure mode could potentially cause or contribute to an adverse event if it were to recur.
 
Event Description
It was reported that during a da vinci-assisted surgical procedure, the permanent cautery hook had no energy when activated. The customer used a backup instrument to continue. The procedure was completed with no reported injury. Follow-up was performed to obtain additional information related to the event. However, as of the date of this report, no further details have been received.
 
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Brand NameENDOWRIST
Type of DevicePERMANENT CAUTERY HOOK
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA
Manufacturer Contact
david wang
3410 central expressway
santa clara, CA 
4085232100
MDR Report Key11768015
MDR Text Key268036362
Report Number2955842-2021-10471
Device Sequence Number1
Product Code NAY
UDI-Device Identifier00886874112311
UDI-Public(01)00886874112311(11)201217(10)N10210104
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 04/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470183-14
Device Catalogue Number470183
Device Lot NumberN10210104 0064
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/30/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/17/2020
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

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