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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS

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INTUITIVE SURGICAL, INC DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS Back to Search Results
Model Number 380677-22
Device Problems Defective Component (2292); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/26/2020
Event Type  malfunction  
Manufacturer Narrative
An intuitive surgical, inc. (isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint. Fse confirmed that the left master tool manipulator (mtm) was causing a hard error code 23025. The fse replaced the surgeon side console mtml. The system has been tested and verified ready for use. The mtm2 has been returned and evaluated by the failure analysis team. Failure analysis investigations confirmed the customer reported complaint of "error 23025. " the issue was replicated during a sine cycle. The master tool manipulator (mtm) refers to the master controllers which provide the means for the surgeon to control the instruments and endoscope inside the patient from the surgeon's side console. One mtm is assigned to the surgeon's left hand (mtml) and one to the right (mtmr). No images or videos were shared for the event. This complaint is being reported based on the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that the system had multiple recoverable faults. System unavailability after start of a surgical procedure (first port incision) could lead to the procedure to be converted/aborted. Although no patient harm occurred, if this malfunction were to recur it could potentially cause or contribute to an adverse event.
 
Event Description
It was reported that during a da vinci-assisted inguinal hernia repair surgical procedure, the customer had repeated recoverable faults. The clinical territory associate (cta) stated that the customer was getting errors 23025 and 23002. The technical support engineer (tse) viewed and confirmed multiple recoverable faults pointing to the master tool manipulator left (mtml) on the surgeon side console (ssc). The intuitive surgical, inc. (isi) tse recommended to perform a hard power cycle on the ssc. Cta stated that the staff has already done this and are currently bringing in another ssc. Site proceeded with the case using another ssc and would like the field engineer to come out as soon as possible to resolve this issue. The procedure was completed with no reported injury. Isi made multiple follow-up attempts to obtain additional information. However, no further details have been received as of the date of this report.
 
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Brand NameDAVINCI XI
Type of DeviceSURGEON SIDE CONSOLE, SMART PEDALS
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA 95051
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA 95051
Manufacturer Contact
david wang
3410 central expressway
santa clara, CA 95051
4085232100
MDR Report Key10880992
MDR Text Key232186485
Report Number2955842-2020-11233
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial
Report Date 10/26/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380677-22
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/03/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/26/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/04/2020
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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