MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; MEGASUTURECUT ND

Model Number	420309-07
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has issued a return material authorization (rma) to have the intuitive device returned.However, isi has not received the mega suturecut needle driver instrument involved with the alleged issue to perform failure analysis.Additional information is being gathered to determine the contribution of the device to the customer reported issue.
Event or Problem Description
It was reported that during a da vinci-assisted ventral hernia tapp surgical procedure, the mega suturecut needle driver instrument had a broken cable.The customer continued and completed the procedure with no further issues.No fragment fell into the patient.No known impact or patient consequence was reported.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained additional information: the reporter confirmed that by "threat", they were referring to the cable.There was no observed intraoperative collision or misuse involving the instrument.There were issues related to the opening/closing of the grips and the left/right motion of the grips.The reporter confirmed that there was no patient injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The mega suturecut needle driver instrument was analyzed and found to have a broken grip cable at the idler pulleys.The cable was fully broken.There was no discoloration, corrosion, or contamination on the cable that would occur from improper flushing or rinsing during reprocessing.Further inspection found no abnormally sharp or damaged components that may contribute.The complaint was confirmed by failure analysis.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: MEGASUTURECUT ND
• 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: 20298328
• Report Number: 2955842-2024-19870
• Device Sequence Number: 7745391
• Product Code: NAY
• UDI-Device Identifier: 00886874111796
• UDI-Public: (01)00886874111796(10)N10210125
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2024

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: 420309-07
• Device Catalogue Number: 420309
• Device Lot Number: N10210125 208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2021
• 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 Age: 35 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian