MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; ENDOSCOPE PLUS

Model Number 470057-08

Device Problem Image Orientation Incorrect (1305)

Patient Problems Hemorrhage/Bleeding (1888); Insufficient Information (4580)

Event Date 02/03/2023

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the cause of the operative complication cannot be determined.Intuitive surgical, inc.(isi) has not received the instrument involved with this event for failure analysis evaluation.A follow-up mdr will be submitted if additional information is obtained.A system log review was performed for this procedure and the following relevant error was observed: error code 256 ¿ emergency stop button was pressed by a user on the patient side cart (psc).An advanced system log review for the 30 degree endoscope plus / universal surgical manipulators was performed for this procedure by an isi advanced failure analysis engineer (afa).Per afa, there was one engagement failure on universal surgical manipulator (usm) 3 with an unknown tool (instrument or scope).There were also several e-stop presses around the time of the engagement failure so those could have been due to the inverted image that the complaint mentions.However, the logs don¿t show anything that can confirm the image was inverted.Not many engagement failures were seen on this arm [usm] aside from these two procedures so it isn¿t necessarily saying that there was something wrong with the arm [usm].This may have been a draping or endoscope issue.This event is being reported due to the following conclusion: during a da vinci-assisted radical prostatectomy with lymphadenectomy procedure, the patient experienced minimally increased blood loss due to the 30 degree endoscope plus experiencing image inversion.The endoscope moved with unintuitive movements with reversed control of the endoscope despite correct alignment and installation.The cause of the operative complication is unknown.

Event Description

It was reported that during a da vinci-assisted radical prostatectomy with lymphadenectomy procedure, the patient experienced minimally increased blood loss due to the 30 degree endoscope plus experiencing image inversion.The issue occurred once during the procedure.The endoscope moved with unintuitive movements with reversed control of the endoscope despite correct alignment and installation.The endoscope did not move freely.Emergency shutdown and restart of the system was initiated.The initial endoscope continued to be used.Per the surgeon, there was a prolongation of the procedure by 15 minutes, but no lasting harm.

• Brand Name: NONE
• Type of Device: ENDOSCOPE PLUS
• 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: 16615068
• MDR Text Key: 312011700
• Report Number: 2955842-2023-11520
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00886874116555
• UDI-Public: (01)00886874116555
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K191736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/25/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 470057-08
• Device Catalogue Number: 470057
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2023
• Initial Date FDA Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2021
• 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: Male