MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; MEGA NEEDLE DRIVER

Model Number	420194-12
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is in progress to determine the cause of this reported event.An rma was issued to evaluate the intuitive surgical, inc.(isi) device.Additional information is being gathered to determine the contribution of the device to the customer reported issue.The root cause of the customer-reported failure mode could not be determined as the product would not been returned for evaluation.
Event or Problem Description
It was reported that prior to the start of a da vinci-assisted pediatric pyeloplasty surgical procedure, the mega needle driver had a torn cable.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the distributor clinical territory associate (cta) and obtained the following additional information: according to the report by the surgical team present at the surgery, the problem of the torn cable was identified before using the instrument, so there was no option for a cable segment to fall into the patient.There was no further information available from that event.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) followed up with initial reporter and obtained the following additional information: the procedure was completed without any complications and delays.There was no patient injury.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The mega needle driver instrument was analyzed and found to have a frayed grip cable at the distal idler pulley.Some filaments of the cable were frayed, but the cable was not fully broken.The frayed cable strands stuck out at the wrist.There was no evidence of discoloration, corrosion, or contamination on the cables to indicate a reprocessing induced issue.The components surrounding the frayed cable did not exhibit abnormal sharp edges or damage that would have contributed to the cable fraying.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: MEGA NEEDLE DRIVER
• 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: 18918874
• Report Number: 2955842-2024-12536
• Device Sequence Number: 15134297
• Product Code: NAY
• UDI-Device Identifier: 00886874111611
• UDI-Public: (01)00886874111611(10)N10210524
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K050369
• 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,Followup
• Report Date (Section B): 02/29/2024

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: 420194-12
• Device Catalogue Number: 420194
• Device Lot Number: N10210524 475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/29/2024
• Supplement Date Received by Manufacturer: 03/21/2024; 04/16/2024
• Initial Report FDA Received Date: 03/16/2024
• Supplement Report FDA Received Date: 03/26/2024; 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2021
• 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: Unknown