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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI PATIENT SIDE CART, 4-ARM

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INTUITIVE SURGICAL, INC DAVINCI XI PATIENT SIDE CART, 4-ARM Back to Search Results
Model Number 380652-50
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 11/04/2021
Event Type  Injury  
Event Description
It was reported that after a da vinci-assisted radical prostatectomy procedure, the patient had a mild form of rhabdomyolysis. The surgeon said he does not believe that a da vinci product contributed to this event and that there was no da vinci product malfunction. Per system log information, the procedure duration was 8-9 hours. Details regarding the patient¿s bmi and positioning during the procedure were unknown. The surgeon reported there was no renal failure. Ck enzymes were used to monitor the rhabdomyolysis, which steadily decreased with treatment. The patient was hospitalized for pain control and iv hydration. It was unclear where the patient was specifically experiencing pain. The surgeon reported that the patient had multiple risk factors that might have contributed to the rhabdomyolysis: the patient was on a statin, is a current smoker, uses gabapentin, and has peripheral artery disease (pad) in a leg. The surgeon reported that a mild case of rhabdomyolysis with no renal failure should not have long lasting effects on the patient. The patient is expected to completely recover from the rhabdomyolysis over time and has already seen significant improvement. The patient¿s pain has reportedly decreased and their ability to walk has improved.
 
Manufacturer Narrative
Based on the current information provided, the cause of the post-operative complication is unknown. There was no report or allegation from the customer of a deficiency of the da vinci system, instrumentation or accessories associated with the reported incident. Therefore, there are no products expected for return to intuitive surgical, inc. (isi) for failure analysis evaluation. A follow up mdr will be submitted if additional information is received. No images or videos were obtained for this reported event. A review of the site's complaint history shows no other complaints related to this event. A review of the system logs for the procedure date of (b)(6) 2021 has been performed and no relevant errors were observed during this procedure. Additionally, none of the instruments used during this procedure have any associated complaints based on a review of the site's complaint history. Based on the information provided, this event is being reported due to the following conclusion: the surgeon of the procedure reported that the patient experienced rhabdomyolysis and required hospitalization. Although the surgeon reported that they do not believe a da vinci product contributed to this event, the root cause of the rhabdomyolysis is currently unknown. There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.
 
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Brand NameDAVINCI XI
Type of DevicePATIENT SIDE CART, 4-ARM
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 Key12929141
MDR Text Key285400914
Report Number2955842-2021-11651
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 Other,Health Professional
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 11/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number380652-50
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/19/2021
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: 12/03/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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