MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SP; CADIERE FORCEPS

Model Number	430009-62
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did not receive the da vinci product with an alleged issue to perform failure analysis.
Event or Problem Description
It was reported that during a da vinci-assisted general right hemicolectomy surgical procedure, the cadiere forceps instrument does not follow the movements of the surgeon.The procedure was completed with a backup da vinci same instrument.The procedure was completed with no reported injury.Intuitive surgical inc.(isi) followed up and obtained additional information.The issue occurred with the surgeon¿s head inside the surgeon console¿s high resolution stereo viewer.The issue occurred 20 minutes into the procedure.The instrument did move in the intended direction.The timing of the instrument movement was no appropriate.There was no interference and no shakiness or friction.There were no external collisions and the issue was intermittent.The instrument was reinstalled to resolve the issue.The drape was not available.
Additional Manufacturer Narrative
The cadiere forceps were found to have a broken roll gear after the housing was removed.The instrument was installed on an in-house system and driven.Instrument exhibited imprecise motion in the roll direction.The grip tips moved in the direction commanded, however a backlash is observed in the roll direction.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: ENDOWRIST SP
• Common Device Name: CADIERE FORCEPS
• 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: 20163379
• Report Number: 2955842-2024-19054
• Device Sequence Number: 20673460
• Product Code: NAY
• UDI-Device Identifier: 00886874115213
• UDI-Public: (01)00886874115213(11)240103(10)U11240103(91)0004
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2024

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: 430009-62
• Device Catalogue Number: 430009
• Device Lot Number: U11240103 0008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2024
• Supplement Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2024
• 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