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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI FENESTRATED BIPOLAR FORCEPS

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INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI FENESTRATED BIPOLAR FORCEPS Back to Search Results
Model Number 420205-16
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/14/2020
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the fenestrated bipolar forceps instrument involved with this complaint and completed the device evaluation. Failure analysis confirmed the reported complaint. The instrument was found to have charring and localized melting at the grip base between the grips. This failure is most commonly caused by insulation degradation and carbonized tissue creating a conductive path. The fenestrated bipolar forceps instrument passed the electrical continuity test. The root cause of the thermal damage between the grips is attributed to use. It was noted the instrument had 6 lives remaining. The instrument logs show that the customer last used the fenestrated bipolar forceps instrument (part # 420205-15, lot # n12200803-0827) on (b)(6) 2020 during a total benign hysterectomy procedure on system serial# (b)(4). The instrument had 6 lives remaining. A review of the site's system logs for the reported procedure date was performed and no related system errors were noted to have occurred during the surgical procedure that would have likely caused or contributed to the reported complaint. This complaint is being reported due to the following conclusion: it was reported the fenestrated bipolar forceps instrument had burnt plastic at the distal end. At this time, it is unknown what caused the thermal damage to occur. 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 the fenestrated bipolar forceps instrument had burnt plastic on the end. No further details, including when the issue was identified, were provided. There was no reported injury or harm. Intuitive surgical, inc. (isi) followed up with the initial reporter and obtained the following additional information: the initial reporter informed isi that the instrument had been dropped off on her desk with limited information, and no additional information could be provided. Isi made multiple additional follow-up attempts to obtain additional information. No further details have been received as of the date of this report.
 
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Brand NameENDOWRIST;DAVINCI SI
Type of DeviceFENESTRATED BIPOLAR FORCEPS
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 Key14325477
MDR Text Key291191220
Report Number2955842-2022-11471
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,User Facility
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial
Report Date 12/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number420205-16
Device Catalogue Number420205
Device Lot NumberN12200803
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2020
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/03/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/30/2020
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

Patient Treatment Data
Date Received: 05/07/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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