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

Model Number	470381-12
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has not received the product involved with the alleged issue to perform failure analysis.A follow-up mdr will be submitted if the product is returned (post failure analysis evaluation) or if additional information is received.
Event or Problem Description
It was reported that during a da vinci-assisted pancreatoduodenectomy surgical procedure, the reducer got damaged and the metal ring fell into the patient's abdomen.The procedure was completed.Intuitive surgical, inc.(isi) obtained the following information based on follow-up: when the instrument was removed, a fragment fell inside the patient.The instrument was in use for 2.5 hours.All fragments were retrieved and confirmed by a diagnostic laparoscopy.A laparoscopic instrument was used to remove the fragment.No post-operative tests were conducted.The patient has not returned to the hospital due to post-surgical complications.The instrument was inspected prior to use with no damage observed.The surgeon did not notice issues with the functionality of the instrument.The instrument did not collide with any instruments or hard material.The surgical staff felt no resistance upon removing the instrument.Upon final removal of the instrument, the wrist was straightened, the staff noticed no damage to the cannula, and there was no further damage to the instrument.

• Brand Name: ENDOWRIST
• Common Device Name: REDUCER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 20074680
• Report Number: 2955842-2024-18478
• Device Sequence Number: 3048098
• Product Code: NAY
• UDI-Device Identifier: 10886874112585
• UDI-Public: (01)10886874112585(10)L80221020
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K162411
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/29/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 470381-12
• Device Catalogue Number: 470381
• Device Lot Number: L80221020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2022
• 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: 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown