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Model Number 380614-07
Device Problems Device Displays Incorrect Message (2591); Intermittent Loss of Power (4016)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/23/2020
Event Type  malfunction  
Manufacturer Narrative
An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint. The fse upgraded the medical grade power supply (mgps) to the newer redundant power supply. After part replacement, the system seemed to be fine but after about 20 minutes, it switched over to battery again. The auxiliary power board (apb) board was replaced and system seemed to be operating normally initially and then, after 20 minutes switched to battery again. The old apb board was reinstalled, all connections for power was checked and the issue still reoccurred. Fse then checked the integrity of the power cord and found that when the cord was moved around, it intermittently switched the psc to normal power and then to battery. The power cord was replaced to resolve the issue. The upgraded mgps was left in the system. The system was tested and verified as ready for use. The unit was returned for failure analysis but the reported failure of ¿no battery message¿ could not be confirmed or replicated. The unit was installed into the test system and the patient side cart (psc) was powered up. The power supply passed current/voltage check and fan was running. The unit was left idle in normal mode for ten minutes and underwent ten power cycles without any issue or errors. There was no trouble found with the unit. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. No image or video clip for the reported event was submitted for review. A review of the site's system logs for the reported procedure date was conducted. Investigation revealed the following possible related system errors: error 817 which points to psc loss of ac power and switched to battery. The error occurred prior to following and was recovered by the customer. Multiple errors 816 (psc battery capacity detected as low) occurred as well after following before customer powered the system down. A system log review confirmed that a total hysterectomy procedure was carried out on system (b)(4) on (b)(6) 2020. Based on the information provided at this time, this complaint is being classified as a reportable event due to the following conclusion: the customer converted the procedure to another psc as the patient cart lost power and was running on battery in the beginning of the procedure, after following. Although no patient harm occurred, if this malfunction were to recur it could likely cause or contribute to an adverse event.
Event Description
It was reported that during a da vinci-assisted sacrocolpopexy hysterectomy surgical procedure, the customer received an error message stating "patient cart was intermittently switching over to battery". The intuitive surgical, inc. (isi) technical support engineer (tse) had the customer check the breaker, power cord and outlet power but there were no issues. The tse then had the customer power down and emergency power off (epo) the patient side cart (psc) but the issue persisted. The customer converted the procedure to another psc. There was no reported injury. Isi followed up with the reporter, who was present at the time of the incident, and obtained the following information: the issue occurred during the first case of the day. When she turned on the system in the morning, she noticed that the patient side cart (psc) battery level was yellow. The system was docked and the procedure was commenced. The system kept on giving recoverable errors and the staff would just recover the error each time. The surgeon was aware of the situation but decided to carry on the surgery as the system was still responding to his commands. According to the reporter, the surgeon was going to `get as far in the surgery as he could`as long as the system was still responding'. After about 10 minutes, the circulatory nurse decided to call isi technical support to troubleshoot the issue. They decided to convert the procedure to another psc as the error kept on recurring despite troubleshooting. The surgery was completed robotically and there was no injury to the patient.
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Manufacturer (Section D)
3410 central expressway
santa clara CA 95051
Manufacturer (Section G)
3410 central expressway
santa clara CA 95051
Manufacturer Contact
david wang
3410 central expressway
santa clara, CA 95051
MDR Report Key11165679
MDR Text Key241371845
Report Number2955842-2021-10033
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 12/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380614-07
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/13/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/12/2011
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