MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; HARMONIC ACE

Model Number	420275-03
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The harmonic ace instrument was analyzed and found to have a bent main tube.The bending damage is located at the distal end of the main tube.The instrument was found to have a broken grip at the hole grip.The hole grip is missing.The broken piece was not returned.The complaint was confirmed by failure analysis.
Event or Problem Description
It was reported that the harmonic ace instrument was noted to have an issue.There was no report of patient involvement.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: HARMONIC ACE
• 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: 19727630
• Report Number: 2955842-2024-16937
• Device Sequence Number: 20865717
• Product Code: NAY
• UDI-Device Identifier: 00886874111765
• UDI-Public: (01)00886874111765(10)N10190404
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K112584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/20/2024

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: 420275-03
• Device Catalogue Number: 420275
• Device Lot Number: N10190404 056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2019
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Prefer Not To Disclose