MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI; ENERGY ACTIVATION CABLE, ETHICON

Model Number	371870-05
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	06/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the product for evaluation, but the failure analysis investigations have not been completed.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the energy cable was unable to transmit energy.The user converted to open surgery with a procedure delay greater than 30 minutes.Intuitive surgical, inc.(isi) attempted follow-up to obtain additional information.However, no further details have been received as of the date of this report.
Additional Manufacturer Narrative
The ethicon cable accessory has been returned and evaluated by the failure analysis team.The reported issue with the instrument could not be replicated nor confirmed.Visual inspection displayed no signs of physical damage to the cable.The cable could not be tested for energy transmission due to no fixture availability.No product issue was identified.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: DA VINCI
• Common Device Name: ENERGY ACTIVATION CABLE, ETHICON
• 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: 19712963
• Report Number: 2955842-2024-16690
• Device Sequence Number: 8609030
• Product Code: NAY
• UDI-Device Identifier: 00886874110393
• UDI-Public: (01)00886874110393
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2024

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: 371870-05
• Device Catalogue Number: 371870
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2024
• Supplement Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Prefer Not To Disclose