MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI; ENDOSCOPE PLUS

Model Number 470057-08

Device Problem Image Orientation Incorrect (1305)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/07/2023

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the cause of the operative complication was traced to component failure and user error.Intuitive surgical, inc.(isi) received the 30 degree endoscope plus associated with this complaint and completed investigations.Failure analysis investigations confirmed the customer reported complaint.The endoscope was found to have friction issues.This failure is attributed to a component failure.The sapphire distal window was found to be cracked and visual damage was found on a cable.These failures are attributed to user error.A follow-up mdr will be submitted if additional information is obtained.A system log review was performed for this procedure: no relevant errors were observed during this procedure.A universal surgical manipulator (usm) log review was performed for this procedure by an isi advanced failure analysis engineer (fae).Per the fae, there were a couple of engagement failures with an endoscope on arm [usm] 3.Not many engagement failures on this arm [usm] were seen so there is not necessarily something wrong with the arm [usm].This may have been a draping or endoscope issue.This complaint 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" as a result of the surgical staff observing inverted imaging associated with the use of a 30 degree endoscope plus.

Event Description

It was reported that during a da vinci-assisted radical prostatectomy with lymphadenectomy procedure, the surgical staff observed inverted imaging while using a 30 degree endoscope plus.The issue occurred once during the procedure.The surgeon indicated that the endoscope moved with unintuitive movements and with reversed control despite correct alignment and installation.The endoscope was pulled out of the patient side cart (psc) and reseated which successfully cleared the issue.Per the surgeon, there was a "prolongation of the procedure" by 15 minutes and "minimally increased blood loss, but no lasting harm." the estimated blood loss associated with the event is unknown.In addition, the source of the bleeding and what medical intervention, if any, was rendered due to the complication are unknown an intuitive surgical, inc.(isi) technical support engineer (tse) reviewed the logs after procedure completion and found an error pointing to a scope engagement issue.

• Brand Name: DA VINCI
• 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: 16524740
• MDR Text Key: 311123090
• Report Number: 2955842-2023-11224
• 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
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/08/2023

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: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/08/2023
• Initial Date FDA Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2022
• 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