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

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.

• Brand Name: DA VINCI
• Type of Device: PATIENT 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 Key: 12603207
• MDR Text Key: 275882124
• Report Number: 2955842-2021-11265
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• 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: 09/15/2021
• 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 Number: N/A
• Patient Sequence Number: 1