MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI; PATIENT SIDE CART, RECERTIFIED

Model Number	380686-04
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information gathered, there is no indication or report that a davinci product caused or contributed to the incidents.No device was received for failure analysis investigations.A review of the clinical development engineering (cde) report for the needle associated with this event has been performed by an intuitive surgical, inc.(isi) cde team member.The following additional information was provided: based on the review of this article the allegation is that during removal of two different suture threads with needles attached through a 12mm cannula (unclear if it was an intuitive cannula or a 3rd party product) using a laparoscopic needle holder one of the needles was lost.In image a we can see a robotic needle driver on the right (unclear what size or type of needle driver as armpod messages are not visible) and a laparoscopic needle holder grasping 2 threads of suture.Image b shows a needle stuck in the body wall with no suture attached to it.Image c shows the laparoscopic needle holder going to grasp the lost needle.Based on the images and content of the article there does not appear to be any allegation against an isi product and the needle was retrieved with no harm to the patient.Source of the article: koida y., kiuchi h., yoshioka f., soda t., sekii k., (2023) lost needle during robot-assisted radical prostatectomy: a case report and literature review.2023 koida et al.Cureus 15(7): e42119.Doi 10.7759/cureus.42119.
Event or Problem Description
During review of a literature article involving a da vinci-assisted radical prostatectomy, the following incident was noted.After the suturing for the vesicouretheral anastomosis, one needle was noted missing during removal through 12mm cannula.A search using the da vinci system was performed in the abdominal cavity, but the needle was not found.The da vinci system was then undocked and the needle was found attached to the abdominal wall using laparoscopic endoscope and was successfully retrieved.The procedure was completed.

• Brand Name: DAVINCI SI
• Common Device Name: PATIENT SIDE CART, RECERTIFIED
• 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: 19052424
• Report Number: 2955842-2024-13098
• Device Sequence Number: 15500826
• Product Code: NAY
• UDI-Device Identifier: 00886874110775
• UDI-Public: (01)00886874110775
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K081137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/11/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: 380686-04
• Device Catalogue Number: 380686
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Initial
• 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
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 99 KG