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

Model Number	470381-12
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product involved with this event has been requested to be returned, but has not yet been received.Review of the provided image by a regulatory post market surveillance analyst is consistent with the reducer having detached pieces.Root cause of the failure mode cannot be confirmed without the returned device.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the reducer had a metal part and plastic pieces fall off when removing the cannula from the patient.All pieces of the reducer were retrieved during the same procedure.The procedure was completed using a backup reducer.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: all the fragments were retrieved using tweezers.The customer was unable to specify how they confirmed that all the fragments were retrieved.There was no additional surgical procedure or post-operative tests performed.The instrument was in use for 2 minutes prior to the break.The instrument was not inspected prior to use and there was no instrument collision during the procedure.It was not specified if the instrument was removed during the procedure prior to the break.The patient has not returned due to post-surgical complications.The referenced reducer was analyzed by isi.Investigation found a metal tip dislodged from the plastic shaft.The distal end of the plastic shaft was found with small broken pieces that fell off as a result of being exposed from the dislodged metal tip.There was no material missing as the broken pieces were returned and pieced back together.
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: 19031690
• Report Number: 2955842-2024-13075
• Device Sequence Number: 17909692
• Product Code: NAY
• UDI-Device Identifier: 10886874112585
• UDI-Public: (01)10886874112585(10)L10220318
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 03/07/2024

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: L10220318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/07/2024
• Supplement Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2022
• 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: Unknown
• 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