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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI MONOPOLAR CAUTERY

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INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI MONOPOLAR CAUTERY Back to Search Results
Model Number 420142-04
Device Problems Thermal Decomposition of Device (1071); Arcing (2583)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/25/2020
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the monopolar cautery involved with this complaint and completed the device evaluation. Failure analysis investigations confirmed the reported issue. The instrument was found to have thermal damage to its grip tips and broken electrical contacts at the distal tip. The instrument failed the electrical continuity test. Functional testing of energy delivery could not be performed due to the thermal damage. While the root cause for this failure is typically attributed to the user, it is unknown what caused the damage for this event. Additional finding not related to the reported thermal damage: the instrument was found to have a dislodged flush tube inside the housing. Root cause of this failure is typically attributed to the user. A review of the instrument log for the monopolar cautery (part # 420142-04, lot # s10131218 983) associated with this event has been performed. The instrument was last used on (b)(6) 2020 on system (b)(4). The alleged event occurred on the 14th use. There is no indication that the instrument was used in subsequent procedures after the alleged event reported on this record. No image or video clip for the reported event was submitted for review. This complaint is being reported due to the following conclusion: the monopolar cautery instrument tip was found melted and charred. Melting/charring is evidence of the deliverance of electrical current 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 central processing, the monopolar cautery instrument tip was found melted and charred. It was removed from service and replaced. There was no reported injury. Intuitive surgical, inc. (isi) obtained the following information about the complaint: there was nothing abnormal at the visual inspection on the sterile field. No arcing was observed. The monopolar cord was not connected to a bipolar instrument. The customer used conmed system 5000 generator with settings: cut: 40, coag: 40, bip 35. The monopolar scissors were used during 90% of case with the maryland bipolar forceps. Often during the dissection, the tips were covered in carbonized tissue requiring being removed and cleaned. There was no patient harm and the surgery completed as planned.
 
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Brand NameENDOWRIST;DAVINCI SI
Type of DeviceMONOPOLAR CAUTERY
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 Key14332357
MDR Text Key291191319
Report Number2955842-2022-11474
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K050369
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 10/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number420142-04
Device Catalogue Number420142
Device Lot NumberS10131218 983
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/30/2020
Date Manufacturer Received10/26/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/18/2013
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: 05/08/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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