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

Model Number 380652-35

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Nerve Damage (1979); Pain (1994)

Event Date 03/15/2019

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the root cause of the customer reported failure mode cannot be determined or is unknown. If additional information is received, a follow-up mdr will be submitted. A site complaint history review was conducted and found no other complaints related to this product. No image or video clip for the reported event was submitted for review. System error log review was conducted on 09-jun-2021 for an 81 minutes procedure on (b)(6) 2019 on system (b)(4). There were no observed events in the system logs that would suggest a product issue and logged events are in line with normal system functionality. A review of the instrument logs was also performed. There was only one single use item recorded which was a suction irrigator. All other instruments recorded for this procedure were reusable instruments. All reusable instruments used in the case were used in subsequent procedures through their respective end of uses with exception of the endoscope which is still in use. A site complaint history review shows no complaint filed against any of the instruments. While there is no known allegation of a reportable event from a qualified medical professional, this event is considered a reportable event as the patient alleged nerve damage during a da vinci-assisted procedure and also alleged additional hospitalization, a blood transfusion, and chronic pain post-operatively. At this time, the root cause of the alleged intra-operative and post-operative complications are unknown.

Event Description

It was initially reported by the patient that during a da vinci-assisted rectal prolapse procedure on (b)(6) 2019, allegedly, some of the patient¿s ¿nerves were burned¿ and the patient ¿had lots of bleeding¿ from her rectum and bladder. The patient believed that the burns may have been caused by ¿a laser or something¿ related to the ¿robot arm¿. The patient said that she has not been able to control when she goes to the bathroom; she has bowel movements and urination uncontrollably. The patient allegedly has severe pain ¿with bladder, rectal area, kidneys, and back¿. She also alleged that her foot twitches and she has muscle spasm. She allegedly has an fda report and she believes that the surgery was not approved. She has followed up with the surgeon of record who performed the initial da vinci-assisted procedure but the surgeon claims to have said that ¿the bladder issues were not his area¿. The patient is currently seeing a physician at the university of (b)(6) medical center in (b)(6). The patient reported having ¿very high medical bills and not receiving help or support from hospital¿. She is scared to go to another doctor, afraid of what to do, and cannot pay for it. She said that her insurance ¿dropped her and she has a (b)(6) bill¿. On 09-jun-2021, intuitive surgical, inc. (isi) obtained the following additional information from the patient regarding the reported event: a (b)(6) year old female patient alleged that during a da vinci-assisted rectal prolapse procedure on (b)(6) 2019, the patient was injured. A nerve was allegedly burned during the procedure which resulted in her having trouble with uncontrollable urination and defecation post-operatively. The patient ¿left the hospital with a foley bag¿ (foley catheter bag) as she was unable to urinate; the foley catheter bag remained from (b)(6) to (b)(6) 2019. The patient alleged having excessive post-operative rectal and bladder bleeding for which a blood transfusion was administered at a hospital post-operatively. The patient also reported having leg and hand swelling, her foot twitches, and she has muscle spasm. The surgeon of record allegedly referred the patient to a urologist for follow-up. The patient is currently seeing a urology surgeon for a possible future bladder reconstruction surgery. Additional procedure and event detail was requested but was not provided. On 11-jun-2021, intuitive surgical, inc. (isi) obtained the following additional information regarding the reported event: the console surgeon of record is not aware of any issues, nor was there an allegation of any malfunction of a da vinci product or known adverse event.

• 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: david wang ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 12112762
• MDR Text Key: 267861973
• Report Number: 2955842-2021-10740
• Device Sequence Number: 1
• Product Code: NAY
• 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
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/08/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 380652-35
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2016
• 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