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

Model Number	470381-11
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis investigations replicated/confirmed the customer reported complaint.Failure analysis found the primary failure of broken reducer to be related to the customer reported complaint.For clarification, the reducer cap was found to be separated from the cannula.There were no signs of physical or cosmetic damage to the cap or the cannula.The septum shows no signs of damage, and remains installed in the cap.No pieces are missing.The root cause of this failure is attributed to a component failure.A review of the site's complaint history does not reveal any additional complaints involving this product.A log review was not conducted as accessories do not appear in the logs.There was no image or procedure video provided for review.This complaint is reportable due to the following conclusion: the conductive cannula reducer was broken upon opening the packaging.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 during use of the product.Follow-up was attempted, but the patient information were either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The product is not implantable.Is unknown if the initial reporter submitted a report to the fda.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the top piece of the cannula reducer was separated when the package was opened.The cannula reducer was not able to be connected and used due to the separation.The procedure was completed robotically with no reported injury.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
Additional information can be found in the following sections: d9, g3, g6, h2, h3 and h10.Corrections: fields h7 and h9 should be blank as it was determined that this product and failure were not related to a field action.Intuitive surgical, inc.(isi) failure analysis provided additional clarification regarding this product that was returned and analyzed.The metal tip on the reducer did not exhibit any damage or signs of separation from the reducer.The findings during investigation are not related to field action isifa2021-08-r.

• 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: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 13173759
• Report Number: 2955842-2022-10013
• Device Sequence Number: 4998335
• Product Code: NAY
• UDI-Device Identifier: 10886874112585
• UDI-Public: (01)10886874112585(10)L10210719
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 470381-11
• Device Catalogue Number: 470381
• Device Lot Number: L10210719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/07/2021
• Supplement Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 02/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2021
• 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: Unknown