MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; REDUCER

Model Number	470381-11
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	04/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the reducer involved with this complaint and completed the device evaluation.Failure analysis investigations confirmed the customer reported complaint "they found a piece broken off in the patient." failure analysis found the primary failure of dislodged conductor to be related to the customer reported complaint.The accessory was found to have a dislodged conductor.The conductor, measuring 0.440" x 0.560" was returned.No broken or missing pieces were observed.The conductor was reseated on the cannula and could easily be removed with little force.Root cause is not established.Failure analysis found the secondary failure of indentations to be related to the customer reported complaint.Upon visual inspection, the accessory was found to have mechanical indentations on both tabs on the cannula portion.Root cause is not established.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.In addition, this is an accessory, which does not show in the logs.Therefore, an instrument log review of the product related to the complaint cannot be performed.No image or video clip for the reported event was submitted to isi for review.This event is being reported because the reducer had a conductor dislodged and fell inside the patient.The piece was retrieved, and no additional surgical intervention was required.However, unintended piece falling into the patient may require surgical intervention.Failure analysis confirmed the reported issue was attributed to a component failure.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.Blank mdr fields: follow-up was attempted, but the patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Field e4 is blank because it is unknown if the initial reporter submitted a report to the fda.Fields g5, g7, h7, and h9 are not applicable.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the customers were not aware of a piece broke off and fell into the patient until they found it.The piece was retrieved with a backup instrument.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the customer stated that the reducer came completely off and there were no fragments.They did not realize until they saw it lying in the chest cavity.As the issue was identified at the end of the case, they retrieved the reducer with the forceps.There was no damage to the trocar upon inspection.It was unknown why the reducer came off.No photographic images of the device/fragment(s) or a video recording of the procedure was available for isi review.Information regarding patient demographics, relevant testing, and medical history were requested; however, the reporter was not able to provide that information.
Additional Manufacturer Narrative
Refer to the following fields for updated information: g3, g6, h2, h7, h9, and h10.This event was determined to be related to isifa2021-08-r.
Event or Problem Description
Refer to h10/h11 for follow-up information.
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".

• Brand Name: ENDOWRIST
• Common Device Name: REDUCER
• 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: 11861451
• Report Number: 2955842-2021-10541
• Device Sequence Number: 3193789
• Product Code: NAY
• UDI-Device Identifier: 10886874112585
• UDI-Public: (01)10886874112585(10)L10210212
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K162411
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall,Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/26/2021

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: 470381-11
• Device Catalogue Number: 470381
• Device Lot Number: L10210212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 12/07/2021; 04/26/2021
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 01/05/2022; 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: ISIFA2021-08-R
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Female