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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 380677-13
Device Problem No Display/Image (1183)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/24/2021
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. The fse replaced the high resolution stereo viewer (hrsv). The system was tested and verified as ready for use. Isi has not received the hrsv for evaluation. Therefore, the root cause of the customer reported failure mode has not been determined. A follow-up mdr will be submitted if additional information is obtained. A review of the site's complaint history does not show any additional complaints related to this product or this event. A review of the site's system logs for the reported procedure date was conducted. Investigation revealed there were no related system errors to have occurred during the surgical procedure that would have likely caused or contributed to the reported complaint. No image or procedure video was provided for review. This complaint is being reported due to the following conclusion: system unavailability after start of a surgical procedure could lead to the procedure to be converted/aborted and may lead to an injury due to the patient¿s inability to tolerate a conversion/abortion. 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. Blank mdr fields: follow-up was attempted, but the patient information in sections was either unknown, unavailable, not provided, or not applicable. The expiration date in section is not applicable. Field is not applicable because the product is not implantable. The information for blank fields in section is not available. Fields are not applicable.
 
Event Description
It was reported that during a da vinci-assisted vaginal prolapse repair surgical procedure, the right eye on the surgeon side console (ssc) was black. The site power cycled the system a couple times without success. The technical support engineer (tse) guided the caller to power off the system, exercise the surgeon side console (ssc) circuit breaker, and reconnect the blue fiber cable on both ends. The site verified the right eye had no image during power on. The tse asked the site to modify the high resolution stereo viewer (hrsv) position using manual switches and reboot the system without success. Both eyes were visible on the vision side cart (vsc) touchscreen. The procedure was converted to laparoscopic surgery with no reported injury. Intuitive surgical, inc. (isi) made multiple follow up attempts to obtain additional information, however, no further details have been received as of date of this report.
 
Manufacturer Narrative
An intuitive surgical, inc. (isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint. The fse replaced the high resolution stereo viewer (hrsv). The system was tested and verified as ready for use. Isi has not received the hrsv for evaluation. Therefore, the root cause of the customer reported failure mode has not been determined. A follow-up mdr will be submitted if additional information is obtained. A review of the site's complaint history does not show any additional complaints related to this product or this event. A review of the site's system logs for the reported procedure date was conducted. Investigation revealed there were no related system errors to have occurred during the surgical procedure that would have likely caused or contributed to the reported complaint. No image or procedure video was provided for review. This complaint is being reported due to the following conclusion: system unavailability after start of a surgical procedure could lead to the procedure to be converted/aborted and may lead to an injury due to the patient¿s inability to tolerate a conversion/abortion. 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. Blank mdr fields: follow-up was attempted, but the patient information in sections was either unknown, unavailable, not provided, or not applicable. The expiration date in section is not applicable. Field is not applicable because the product is not implantable.
 
Event Description
It was reported that during a da vinci-assisted vaginal prolapse repair surgical procedure, the right eye on the surgeon side console (ssc) was black. The site power cycled the system a couple times without success. The technical support engineer (tse) guided the caller to power off the system, exercise the surgeon side console (ssc) circuit breaker, and reconnect the blue fiber cable on both ends. The site verified the right eye had no image during power on. The tse asked the site to modify the high resolution stereo viewer (hrsv) position using manual switches and reboot the system without success. Both eyes were visible on the vision side cart (vsc) touchscreen. The procedure was converted to laparoscopic surgery with no reported injury. Intuitive surgical, inc. (isi) made multiple follow up attempts to obtain additional information, however, no further details have been received as of 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
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 Key13027743
MDR Text Key286022425
Report Number2955842-2021-11766
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Distributor
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup,Followup
Report Date 11/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380677-13
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/20/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/19/2018
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: 12/17/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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