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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC DAVINCI PATIENT SIDE CART Back to Search Results
Model Number 380614-11
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/14/2021
Event Type  malfunction  
Manufacturer Narrative
An isi fse was dispatched to the customer site to further investigate the reported complaint. The fse replaced the ecm. The system was tested and verified as ready for use. Isi has not received the ecm for evaluation. Therefore, the root cause of the customer reported failure mode has not been determined. A follow-up mdr will be submitted if additional information is obtained. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. A review of the site's system logs for the reported procedure date was conducted. Investigation revealed there were no related system errors to have occurred during the surgical procedure that would have likely caused or contributed to the reported complaint. Based on the information provided at this time, this complaint is being reported due to the following conclusion: system unavailability after the start of a surgical procedure caused the procedure to be converted to a laparoscopic procedure which could lead to an injury due to the patient¿s inability to tolerate the conversion. While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.
 
Event Description
It was reported that during a da vinci-assisted surgical procedure, the endoscopic camera manipulator (ecm) insertion axis was stuck. The procedure was converted to laparoscopic surgery with no reported injury. Intuitive surgical, inc. (isi) followed up with the isi field service engineer (fse) on 31-may-2021 and obtained the following additional information: system functionality was checked upon system power up. The system initially powered on with no errors. No patient data was available.
 
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Brand NameDAVINCI
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 Key11963709
MDR Text Key267314454
Report Number2955842-2021-10629
Device Sequence Number1
Product Code NAY
UDI-Device Identifier00886874110690
UDI-Public(01)00886874110690
Combination Product (y/n)N
Reporter Country CodeRS
PMA/PMN Number
K081137
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 05/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380614-11
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/26/2013
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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