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

Model Number 380652-31

Device Problem Difficult to Remove (1528)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 05/18/2023

Event Type  Injury  

Manufacturer Narrative

Based on the claim against the product by the customer noting instrument stuck, an investigation is completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The maryland bipolar forceps instrument was analyzed and failure analysis investigations replicated/confirmed the customer reported complaint.Failure analysis found the primary failure of dislodged conductor wire to be related to the customer reported complaint.The instrument was found to have the conductor wire dislodged from connector at back end.It is common for the dislodged wire to become stuck underneath the instrument release buttons which would cause them to not operate properly.The wire insulation was not damaged.There were no signs of thermal damage.The complaint regarding instrument stuck was confirmed by failure analysis, which indicates that the device did contribute to the customer reported issue.Blank mdr fields: the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.Field is blank because the product is not implantable.Field is blank because it is unknown if the initial reporter submitted a report to the fda.Fields are not applicable.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the maryland bipolar forceps instrument was stuck on the universal surgical manipulator (usm) 4.An intuitive surgical, inc.(isi) technical support engineer (tse) confirmed error 22008 via system logs (likely user induced).The customer re-draped the usm 4 and was going to rma failed instrument.Isi followed up with the initial reporter and obtained the following additional information: the maryland bipolar forceps instrument was stuck on the trocar which was successfully removed with no additional issues.The surgeon then decided to abort the procedure due to the patient¿s anatomy being too small.The procedure was gynecology for tubal reversal.The procedure was aborted due to patient anatomy reasons and the patient did not have to return for any additional procedures due to this type of reproductive procedure can only be completed robotically.Due to the patient¿s anatomy being too small, the surgeon referred the patient for invitro and to do other methods.The surgeon recommended various alternative options to the patient to have their issue resolved.

• Brand Name: DAVINCI XI
• Type of Device: PATIENT 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 Key: 17140089
• MDR Text Key: 317296023
• Report Number: 2955842-2023-16362
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110720
• UDI-Public: (01)00886874110720
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380652-31
• Device Catalogue Number: 380652
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/18/2023
• Initial Date FDA Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2015
• 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