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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI PATIENT SIDE CART, 4-ARM

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INTUITIVE SURGICAL, INC DAVINCI SI PATIENT SIDE CART, 4-ARM Back to Search Results
Model Number 380614-09
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/18/2022
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) has requested that the camera head be returned for evaluation, but it has not yet been received. Therefore, the root cause of the customer reported failure mode has not been determined. A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received. The batch lot number was incomplete. Therefore, an instrument log review of the product related to the complaint cannot be performed at this time. A review of the site's complaint history identified no other complaints related to the instrument and/or this event. No image or procedure video was provided for review. This complaint is being reported based on the following conclusion: the customer converted to laparoscopy after the start of the procedure due to a broken camera head. While there was no harm or injury to the patient, system unavailability after the start of a surgical procedure could likely cause or contribute to an adverse event if it were to recur as it may lead to an injury due to the patient¿s inability to tolerate a conversion/abortion. Follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable. The expiration date is not applicable. The product is not implantable.
 
Event Description
It was reported that during a da vinci assisted partial nephrectomy surgical procedure, the fixation of the camera head was found broken. The procedure was converted to laparoscopic surgery. There was no report of patient injury. Per subsequent follow-up, the customer confirmed the endoscope broke at the beginning of the surgery. Since no backup endoscope was available, the surgeon decided to proceed laparoscopically. There was no consequence for the patient. The hospital declined to provide patient information.
 
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Brand NameDAVINCI SI
Type of DevicePATIENT SIDE CART, 4-ARM
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
izabel nielson
3410 central expressway
santa clara, CA 
4085232100
MDR Report Key14132566
MDR Text Key291316085
Report Number2955842-2022-11122
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K081137
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial
Report Date 03/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380614-09
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/27/2012
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

Patient Treatment Data
Date Received: 04/18/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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