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

Model Number	470027-62
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted benign hysterectomy procedure, the 30-degree 8mm endoscope moved freely with uncontrolled motion.The issue occurred while the surgeon was trying to view omentum that was bleeding.As a result, the surgeon had difficulty viewing the surgical field due to the endoscope motion issue.The cause, severity, and blood loss volume of the bleeding are unknown.It is also unknown if any medical intervention was rendered due to the bleeding.This endoscope was replaced with another to continue the procedure.The procedure was reportedly completed robotically.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the 30-degree 8mm endoscope instrument for evaluation.As of the date of this report, the failure analysis investigation has not yet been completed.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the following additional information regarding the reported event: the bleeding was already occurring during this procedure and was not caused by a da vinci product.The surgeon was reportedly trying to move the endoscope to view the anatomy, and the universal surgical manipulator (usm) the endoscope was on was moved in such a way that the endoscope became bent.The bleeding not caused by unexpected movement of an isi product.The bleed was not expected, but was considered minimal.Cautery was used to control the bleeding.No blood transfusions were administered due to this bleeding and the bleeding did not lead to serious deterioration or clinical instability of the patient.This event led to the or staff retrieving a back-up instrument which took over five minutes to retrieve.The 30 degree endoscope was received for failure analysis testing.The endoscope was evaluated and placed on a diagnostic tester or equivalent for functional testing.The light leakage test or equivalent was performed to detect if any image quality defect(s) were detected in either or both eyes.The endoscope was found with an artifact(s) in the right eye and left eye.The endoscope was also placed through friction test using a screening aide to manually rotate the adapter to detect for friction.The camera instrument adapter did not rotate properly and noises were heard during testing and confirmed as binding.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: DA VINCI
• Common Device Name: ENDOSCOPE
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 19531793
• Report Number: 2955842-2024-15335
• Device Sequence Number: 20734618
• Product Code: NAY
• UDI-Device Identifier: 00886874112212
• UDI-Public: (01)00886874112212
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K171426
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2024

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
• Operator of Device: Health Professional
• Device Model Number: 470027-62
• Device Catalogue Number: 470027
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/15/2024
• Supplement Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Prefer Not To Disclose