MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; PROGRASP FORCEPS

Model Number 420093-14

Device Problem Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/31/2023

Event Type  malfunction  

Manufacturer Narrative

Based on the claim against the product by the customer, an investigation was completed to determine the cause of this reported event.An investigation was completed to determine the cause of this reported event.Although the complaint was not confirmed by failure analysis since the instrument was disposed and will not be returned, the information gathered indicates that the device did contribute to the customer reported issue.

Event Description

It was reported that during a da vinci-assisted radical cystectomy w/ ileal conduit surgical procedure, the vision side cart (vsc) powered off.The customer received phone assistance from the technical support engineer (tse).Prior to the call, the user performed troubleshooting by replacing a new power cable and this resolved the issue.The user further noted that at the time of troubleshooting, they utilized the instrument release kit (irk) on the instrument(s) installed into the patient side manipulator (psm) arms; however, they were unable to press the emergency stop button prior to irk application and they observed that the master tool manipulator (mtm) arm moved on its own during troubleshooting right when they were installing and seating the new power cable.The site¿s system logs was reviewed and confirmed a power loss and homing error confirming the issue.Following this, the user was instructed to perform a system power cycle, and if necessary press the e-stop button and then remove the instruments on the psm arms for issue recurrence.The user continued with the da vinci-assisted surgical procedure with no further issue reported and with all psm and mtm arms functionally operational.No known impact or patient consequence was reported.Intuitive surgical, inc.(isi) followed up with the site and obtained the following additional information regarding the reported event: the system was inspected prior to use and no abnormality was confirmed.The vsc powered off during dissection, when the prograsp forceps instrument was grasping the tissue.The irk usage was unable to successfully open the jaws and a laparoscopic instrument was used to open the jaw and release the tissue.The instrument was disposed after removal.Site indicated that the "medical power tap" which was connected to the vsc had a problem and was replaced.The procedure was completed using the same system with all psm/usm arms and mtm arms functionally operational.

Manufacturer Narrative

Further review of the system logs by the isi regulatory post market surveillance (rpms) investigation analyst confirmed that improper use of the instrument release kit (irk) could have potentially caused the master tool manipulator (mtm) to drift during troubleshooting.The procedure was completed with all patient side manipulators (psm) and with both mtms.All psms and mtms were functioning normally.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST;DAVINCI SI
• Type of Device: PROGRASP FORCEPS
• 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: 17206859
• MDR Text Key: 317908835
• Report Number: 2955842-2023-16639
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420093-14
• Device Catalogue Number: 420093
• Device Lot Number: K10220821 543
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/31/2023
• Initial Date FDA Received: 06/27/2023
• Supplement Dates Manufacturer Received: 07/05/2023
• Supplement Dates FDA Received: 07/26/2023
• 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