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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, RECERTIFIED

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INTUITIVE SURGICAL, INC DAVINCI SI PATIENT SIDE CART, 4-ARM, RECERTIFIED Back to Search Results
Model Number 380675-04
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/16/2022
Event Type  malfunction  
Manufacturer Narrative
The intuitive surgical, inc. (isi) field service engineer (fse) followed up with the customer and was informed that the position of the bed and the orientation of the system set-up was the issue. The next procedure was performed with no issues. No site visit was conducted. The system was working properly and no additional action was required. A review of the site's complaint history does not show any additional complaints related to this product. No image or video clip for the reported event was submitted for review. A review of the site's system logs for the reported procedure date was conducted by isi technical support when the customer called for support. Investigation found no errors occurred during the surgical procedure that were related to the reported complaint. No image or procedure video was provided for review. This complaint is not reportable due to the following: system unavailability after start of a surgical procedure could lead to the procedure to be converted and may lead to an injury due to the patient¿s inability to tolerate a 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 hysterectomy surgical procedure, an issue with arm 1 was noted. The caller stated they were unable to rotate it fully and that surgeon converted to the laparoscopic procedure before calling in. An intuitive surgical, inc. (isi) technical support engineer (tse) found no errors in logs and the site stated that the surgeon might have had a cannula too far up. The customer had a case to follow and would call back if the issue returns. The site completed the procedure laparoscopically with no reported injury. Isi made multiple follow-up attempts to obtain additional information. However, no further details have been received as of the date of this report.
 
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Brand NameDAVINCI SI
Type of DevicePATIENT SIDE CART, 4-ARM, RECERTIFIED
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 Key13812791
MDR Text Key297076251
Report Number2955842-2022-10657
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123463
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 02/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380675-04
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/16/2022
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

Patient Treatment Data
Date Received: 03/18/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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