MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; LARGE SUTURE CUT NEEDLE DRIVER

Model Number	420296-07
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has not received the large suturecut needle driver instrument for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the instrument is returned (post failure analysis evaluation) or if additional information is received.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the large suturecut needle driver instrument steel wire was fractured.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the isi clinical sales representative (csr) and obtained the following additional information: the instrument was inspected prior to use and there was no damage or abnormality in the appearance.The surgical task was a prostatectomy - radical salvage.The instrument did not collide with any other instrument or tool during the procedure.It was unable to be determined if issues were related to opening/closing of the grips, it was a steel wire fracture.It was unable to be determined if issues were related to left/right (yaw) motion of the grips, it was a steel wire fracture.It was unable to be determined if issues were related to up/down (pitch) motion of the wrist, it was a steel wire fracture.Yes, two cables were visibly protruding from the distal end of the instrument.No fragment fell inside the patient.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The large suturecut needle driver instrument was analyzed and was found to have a broken grip cable at the grip hub.The cable was fully broken.There was no evidence of discoloration or corrosion/contamination on the cables to indicate a reprocessing-induced issue.The components surrounding the broken cable did not exhibit abnormal sharp edges or damage that would have contributed to the cable breaking.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: LARGE SUTURE CUT NEEDLE DRIVER
• 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: 19824072
• Report Number: 2955842-2024-17442
• Device Sequence Number: 12931585
• Product Code: NAY
• UDI-Device Identifier: 00886874111789
• UDI-Public: (01)00886874111789(10)K10220605
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K050369
• 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): 07/04/2024

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: 420296-07
• Device Catalogue Number: 420296
• Device Lot Number: K10220605 552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/04/2024
• Supplement Date Received by Manufacturer: 08/11/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2022
• 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: Male