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	12/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has not received the reducer 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 product is returned and evaluated and/ or if additional information is received.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 appear 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 metal part of the reducer¿s tip was separated and could fall into the patient¿s body.At this time, it is unknown what caused the tip to separate from the reducer.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 as unintended items falling into the patient may require surgical intervention.
Event or Problem Description
It was reported that during a da vinci-assisted ventral hernia surgical procedure, the customer used the reducer on a 12mm trocar; however, the metal part at the tip of reducer was separated.Although the metal part did not fall inside the patient's body, the customer was concerned that it could.A backup reducer was used to continue the procedure.The procedure was completed with no report of patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the reducer was inspected prior to use with no damage observed.The customer confirmed that nothing fell inside of the patient and that there was no patient injury/harm.
Additional Manufacturer Narrative
D11-intuitive surgical, inc.(isi) received the reducer involved with this complaint and completed the device evaluation.Failure analysis investigations replicated and confirmed the customer reported complaint "during procedure, metal part at the tip of reducer was separated." failure analysis found the primary finding of reducer broken to be related to the customer reported complaint.The reducer shaft was found to be broken, causing the metal tip to break off.There were no broken pieces missing.Root cause of this failure is attributed to user mishandling/ misuse.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• 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: 13173794
• Report Number: 2955842-2022-10014
• Device Sequence Number: 4664618
• Product Code: NAY
• UDI-Device Identifier: 10886874112585
• UDI-Public: (01)10886874112585(10)L10210514
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K162411
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2021

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: L10210514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2021
• Supplement Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 03/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2021
• 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