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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 380652-20
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Pain (1994); Swelling (2091)
Event Date 08/08/2017
Event Type  Injury  
Manufacturer Narrative
Based on the information provided, isi has not determined the root causes for the alleged post-operative complications experienced by the patient. If additional information is received a follow-up mdr will be submitted to the fda. Isi has reviewed the site¿s system logs with a procedure date of (b)(6) 2017. No related system errors were found to have occurred during the surgical procedure. Based on the current information provided, this complaint is being reported due to the following conclusion: since the completion of a da vinci-assisted hysterectomy procedure, the patient has reported chronic pain, swelling, and the formation of a large hematoma. At this time, the root causes of the patient's post-operative complications remain unknown.
 
Event Description
It was reported that after a da vinci-assisted hysterectomy procedure, the patient developed a large hematoma at an unspecified location. The patient was informed by the surgeon that the hematoma was typical after a robotic procedure. The patient also reported daily pain and swelling since the procedure was performed. At this time, the root cause of the patient's post-operative complication is unknown. On january 2, 2018, the patient provided additional information regarding the reported issue: the post-operative complication has left continuous swelling, pain, disfigurement, and discoloration. On january 9, 2018, intuitive surgical, inc. (isi) contacted the patient and obtained additional information regarding the reported issue: right after the procedure was completed, the patient noticed a huge bruise near her belly button and was in extreme pain. The bruise was noted to be discolored. The patient was given pain medication and antibiotics and was kept overnight. The patient was discharged the following day and was told by the hospital staff that the pain was normal after a procedure. However, the patient reported that the pain was debilitating. At an unspecified date post-surgery, the patient noted a large amount of blood in her urine coming from her vagina. The patient contacted the hospital and was informed that this was normal. Two weeks afterwards, the patient returned to the hospital due to the pain and had an ultrasound performed. The ultrasound revealed an infection and vaginal cuff dehiscence. The patient was admitted to the hospital for unspecified treatment and has reportedly been in and out of the hospital since that time due to the extreme pain. The patient allegedly was not informed about all of the possible surgical complications by the surgeon before the procedure took place.
 
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Brand NameDAVINCI XI
Type of DevicePATIENT SIDE CART, 4-ARM
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
950 kifer rd.
sunnyvale CA 94086
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
950 kifer rd.
sunnyvale CA 94086
Manufacturer Contact
pat flanagan
950 kifer rd.
sunnyvale, CA 94086
4085232100
MDR Report Key8240214
MDR Text Key132810485
Report Number2955842-2019-10029
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 consumer
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 12/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number380652-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/09/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/24/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 01/11/2019 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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