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

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.

• Brand Name: DAVINCI SI
• Type of Device: PATIENT 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 Key: 13812791
• MDR Text Key: 297076251
• Report Number: 2955842-2022-10657
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123463
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Nurse
• 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 Received: 03/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380675-04
• 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: 02/16/2022
• 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 Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Female