• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

INTUITIVE SURGICAL, INC ENDOWRIST PERMANENT CAUTERY HOOK Back to Search Results
Model Number 470183-14
Device Problems Break (1069); Defective Device (2588); Detachment of Device or Device Component (2907)
Patient Problem Insufficient Information (4580)
Event Date 11/24/2021
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the permanent cautery hook instrument involved with this complaint and completed the device evaluation. Failure analysis investigation confirmed the customer reported complaint. Failure analysis found the primary finding of ceramic sleeve broken to be related to the customer reported complaint. The instrument was found to have a broken ceramic sleeve with no missing pieces. The root cause of broken instrument ceramic sleeve is typically attributed to mishandling / misuse, such as excess force applied to the distal end of the instrument or accidental collisions. Additional finding related to the customer reported complaint was thermal damage located where the ceramic sleeve broke off. The root cause of this failure is attributed to device design. A review of the site's complaint history does not reveal any related or duplicate complaints involving this product and/or this event. No image or procedure video was provided. A review of the instrument log for the permanent cautery hook instrument (pn# 470183-14 / lot# n10210426-0191) associated with this event has been performed. Per logs, the instrument was last used on 11/24/2021 on system (b)(4) for approximately 30 minutes. The alleged event occurred on the 8th use of the instrument with 2 lives remaining. This complaint is being reported due to the following conclusion: there was evidence of thermal damage proximal to the ceramic sleeve. Thermal damage proximal to where the ceramic sleeve broke off 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.
 
Event Description
It was reported that during a da vinci-assisted abdominoperineal resection surgical procedure, black insulation on the permanent cautery hook instrument was found to be loose and insulation on the tip of the cautery broke off and fell into the patient. The fragment was removed during the same procedure and the procedure was completed with no reported injury. Intuitive surgical, inc. (isi) followed up with the initial reporter for additional information; however, no response has been received at this time.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
izabel nielson
3410 central expressway
santa clara, CA 
4085232100
MDR Report Key13259171
MDR Text Key294165723
Report Number2955842-2022-10066
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Distributor
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial
Report Date 12/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2022
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 NumberN10210426 0191
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/15/2021
Date Manufacturer Received12/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/22/2021
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: 01/14/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
-
-