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

Model Number	420049-13
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The cadiere forceps instrument has not been returned to isi for evaluation.Therefore the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the instrument is returned (post engineering evaluation) or if additional information is received.No image or video clip for the reported event was submitted for review.A review of the instrument log for the cadiere forceps instrument (pn# 420049-13 / lot# n10210125 655) associated with this event has been performed.Per logs, the instrument was last used on (b)(6) 2021 on system sh2407 for approximately 0:15:49.The alleged event occurred on the 6th use of the instrument.A review of the site's complaint history does not reveal any related or duplicate complaints involving this product and/or this event.This complaint is being reported based on the following conclusion: it was reported that the tip of the cadiere forceps instrument became loose and fell into the surgical field.The fragment was retrieved during the same procedure and a backup instrument of the same type was used to complete the procedure with no reported injury.Unintended fragments falling inside the patient may require surgical intervention.Although there was no patient injury reported, if the failure were to recur, it could cause or contribute to an adverse event.In addition, at this time, it is unknown what caused the issue to occur.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the cadiere forceps instrument was not responding well to the commands when part of the instrument tip became loose and fell into the surgical field.The fragment was retrieved, a backup instrument of the same type was used, and the procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the customer and obtained the following additional information: the customer reported the instrument was inspected prior to use with no issues identified.No intraoperative collisions occurred.All of the fragments were confirmed to have been retrieved during the same procedure by the assistant surgeon.No procedure video was available.
Additional Manufacturer Narrative
D11 - the cadiere forceps instrument has been returned and evaluated by the failure analysis team.Failure analysis found the primary finding of grip tip broken to be related to the customer reported complaint.The instrument was found to have a broken grip at the grip base.A piece approximately 0.213" x 0.640" was found to be broken off the yaw pulley.The broken piece was not returned.The root cause of the broken instrument grip tips is typically attributed to mishandling / misuse, such as excess force applied to the instrument jaws.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
Based on a re-evaluation of the complaint information, this complaint has been reclassified as an adverse event and product problem rather than just a product problem, as previously reported.Corrected information can be found the following field: b1, b2, and h1.B1 updated from "product problem" to "adverse event and product problem".B2 updated to "required intervention".H1 updated from "malfunction" to "serious injury".
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: CADIERE 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: david wang ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 12381060
• Report Number: 2955842-2021-11012
• Device Sequence Number: 19143656
• Product Code: NAY
• UDI-Device Identifier: 00886874111338
• UDI-Public: (01)00886874111338(10)N10210125
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2021

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: 420049-13
• Device Catalogue Number: 420049
• Device Lot Number: N10210125 655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2021
• Supplement Date Received by Manufacturer: 12/16/2021; 07/30/2021
• Initial Report FDA Received Date: 08/27/2021
• Supplement Report FDA Received Date: 01/11/2022; 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2021
• 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
• Patient Sex: Unknown