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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI MARYLAND BIPOLAR FORCEPS Back to Search Results
Model Number 420172-17
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/08/2022
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received (b)(4) involved with this complaint and completed the device evaluation. Failure analysis investigation revealed that the instrument was installed onto a test system and passed the recognition and engagement tests. The instrument moved intuitively with full range of motion in all directions. The grips opened and closed properly. No recognition or engagement error codes were found in logs. Additionally, the instrument was tested multiple times and passed with no issues. Additional observation not reported was the instrument was found to have thermal damage on the bipolar yaw pulley. The instrument passed the electrical continuity. The root cause of this failure is attributed to mishandling/misuse. A review of the site's complaint history identified no other complaints related to the instrument and/or this event. No image or procedure video was provided for review. Verification of the instrument logs cannot be performed because the system was not online at the time. Based on the failure analysis, this complaint is being classified as a reportable event due to the following conclusion: the instrument had thermal damage on the bipolar yaw pulley. The instrument passed the electrical continuity. The root cause of this failure is attributed to mishandling/misuse. 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. Follow-up was attempted, but patient information in sections was either unknown, unavailable, not provided, or not applicable. The expiration date for section is not applicable. Field is blank because the product is not implantable. Information for the blank fields in initial reporter is not available. Fields are not applicable.
 
Event Description
It was reported that prior to a da vinci-assisted surgical procedure, (b)(4) was not recognized. A backup instrument of the same type was used and the procedure was completed with no reported injury. Intuitive surgical, inc. (isi) made follow up attempt to obtain additional information. However, no further details have been received as of the date of this report.
 
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Brand NameENDOWRIST;DAVINCI SI
Type of DeviceMARYLAND 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 Key14299195
MDR Text Key290904081
Report Number2955842-2022-11419
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeAR
PMA/PMN Number
K050369
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial
Report Date 04/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number420172-17
Device Catalogue Number420172
Device Lot NumberN10210215 0468
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/04/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/11/2021
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: 05/06/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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