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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI PATIENT SIDE CART

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INTUITIVE SURGICAL, INC DA VINCI PATIENT SIDE CART Back to Search Results
Model Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Incontinence (1928); Insufficient Information (4580)
Event Type  Injury  
Manufacturer Narrative
Based on the current information provided, the root cause of the customer reported issue cannot be determined or is unknown. If additional information is received, a follow-up mdr will be submitted. Isi was unable to conduct system or instrument log review due to lack of information on file at this time. There is no specific allegation to investigate. Unable to conduct site history complaint review as site information is unknown. No image or video clip for the reported event was submitted for review. There is insufficient information provided to suggest that an isi product malfunctioned, nor is there any confirmed site, procedure, da vinci system, or da vinci instrumentation information. While there is no specific allegation to investigate at this time, there was a report that after a da vinci procedure for uterus removal, a patient experienced physical changes to her stool, her sleep patterns, and her urinary continence. Additional details were requested by the isi cs representative but were not provided by the initial reporter. Isi has reached out to the initial reporter to obtain additional information but has not yet received a response. Additional event details and the root cause of the reported event are unknown.
 
Event Description
An intuitive surgical, inc. (isi) customer service (cs) representative received an incoming call and it was initially reported that an unspecified patient had a da vinci surgery for uterus removal and that she had physical changes afterwards to her stool, her sleep patterns, and her urinary continence. When additional details were requested, they were refused by the initial reporter. No hospital, surgeon, procedure date/date range, or patient information was able to be obtained. Isi has reached out to the initial reporter to obtain additional information but has not yet received a response.
 
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Brand NameDA VINCI
Type of DevicePATIENT SIDE CART
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 Key12603207
MDR Text Key275882124
Report Number2955842-2021-11265
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
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
Report Date 09/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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

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