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

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.

• Brand Name: DAVINCI XI
• Type of Device: PATIENT 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 Key: 12929141
• MDR Text Key: 285400914
• Report Number: 2955842-2021-11651
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110720
• UDI-Public: (01)00886874110720
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• 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 Received: 12/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380652-50
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Male