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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC UNKNOWN N/A

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INTUITIVE SURGICAL, INC UNKNOWN N/A Back to Search Results
Model Number UNKNOWN
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Manufacturer Narrative
The product is not expected to be returned for evaluation because the event occurred on an undetermined date in the past. Therefore, failure analysis of the product related to the complaint cannot be performed. A follow-up mdr will be submitted if additional information is received. A review of the site's complaint history does not show any additional complaints related to this event. No image or video was provided by the site for review. The event date, system information, and specific instrument used are not available. Therefore, no log reviews can be performed. This complaint is being reported based on the following conclusion: it was reported that during a da vinci-assisted surgery, an instrument fragment fell inside the patient's abdomen. The fragment was identified by the surgical staff, but since the size of the fragment was reportedly less than 2 mm in size, they opted to not retrieve it. The fragment was retained inside the patient's anatomy. There was no report of injury resulting from the patient retaining a foreign object, however unintended fragments falling inside the patient may require surgical intervention. At this time, it is unknown what caused the instrument breakage to occur and the fragment to subsequently fall.
 
Event Description
It was reported that a surgeon stated that during a previous da vinci-assisted surgical procedure on an unknown date, "one of my patients had a small piece of the needle driver break off in the abdomen. Because is was less than 2 mm we left it. Can you find out what the needle drivers for the robot are made of - - she wants to have an mri. " this is not a recent incident and the reporter believes it happened a while ago. They are unaware of any further details including the event date. Intuitive surgical, inc. (isi) followed up with the initial reporter on 16-july-2021 and obtained the following additional information: the nurse confirmed that she does not have any further information regarding the event. The nurse does not know specifics of the instrument that was at fault, just that it was some sort of needle drver. The surgeon that reported the issue to her is not available for further questions. The nurse clarified that the patient wanted to do an mri for other medical reasons, but was concerned about the fragment that was left inside of her. Information regarding patient demographics, relevant testing, and medical history was requested, however the nurse was only able to report that the patient was a female.
 
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Brand NameUNKNOWN
Type of DeviceN/A
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 Key12222256
MDR Text Key263369486
Report Number2955842-2021-10851
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
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 06/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
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 Received06/29/2021
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 Unkown
Removal/Correction NumberN/A

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