MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; MONOPOLAR CURVED SCISSORS

Model Number 420179-23

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Perforation of Vessels (2135)

Event Date 07/09/2021

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, the cause of the reported intra-operative complication cannot be determined.At this time, no product is expected to be returned.A follow-up mdr will be submitted if additional information is obtained.An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The reported complaint was not confirmed based on the field evaluation.The fse was unable to replicate the reported problem. the system was tested and verified as ready for use.The system logs for this procedure were reviewed by an isi technical support engineer (tse) during the troubleshooting call with the customer.No errors that were relevant to the reported event occurred during this procedure, based on the log review.The instrument logs were reviewed for all three instruments that were used during this procedure.The monopolar curved scissors instrument was reused in a subsequent procedure with 5 uses remaining.The maryland bipolar forceps and prograsp forceps instruments have not been reused in subsequent procedures and both have a single use remaining.This event is being reported due to the following conclusion: it was reported that the patient's iliac vein sustained an injury during the procedure.The site converted the surgery to an open procedure due to the patient's injury.There was no allegation of malfunction related to any isi system, instrument, or accessory.Additional information related to the event has been requested, but no further details have been provided as of the date of this report.At this time, the status of the patient and the cause of the patient's intra-operative injury remain unknown.Follow-up was attempted, but the patient information was either unknown or unavailable.The expiration date is not applicable.The product is not implantable.

Event Description

It was reported that during a da vinci-assisted hysterectomy procedure that there was a patient injury when the iliac vein was "swiped" with the monopolar curved scissors (mcs).The site converted the procedure to open due to the patient injury.The intuitive surgical inc.(isi) technical support engineer (tse) did not observe any errors in the system logs that would be related to this event when the customer called for support.Intuitive surgical inc.(isi) made multiple follow-up attempts to obtain additional information related to the event.However, no further details have been received as of the date of this report.

• Brand Name: ENDOWRIST;DAVINCI SI
• Type of Device: MONOPOLAR CURVED SCISSORS
• 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 Key: 12292309
• MDR Text Key: 265552321
• Report Number: 2955842-2021-10910
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111505
• UDI-Public: (01)00886874111505(10)N12200831
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 420179-23
• Device Catalogue Number: 420179
• Device Lot Number: N12200831 244
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2020
• 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