MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; ROUND TIP SCISSORS

Model Number	470007-05
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the round tip scissors instrument was damaged.The wire of the instrument was coming out.The procedure was completed robotically with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the da vinci product involved in this complaint to perform failure analysis.At the time of this report, the failure analysis has not been completed.A follow-up mdr will be submitted if additional information is obtained.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the wire was possibly broken.There was no impact to the patient.There was one cable visibly protruding from the distal end of the instrument.The customer is unsure if the protruding cable was the one that controls the opening/closing motion of the jaws or the up/down motion of the wrist.
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 round tip scissors instrument was analyzed and was found to have a frayed pitch cable at the clevis hub.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 or corrosion/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.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Common Device Name: ROUND TIP SCISSORS
• 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: 19481289
• Report Number: 2955842-2024-15482
• Device Sequence Number: 20860631
• Product Code: NAY
• UDI-Device Identifier: 00886874112168
• UDI-Public: (01)00886874112168(11)220217(10)K10220221
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K150284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/15/2024

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: 470007-05
• Device Catalogue Number: 470007
• Device Lot Number: K10220221 0038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/15/2024
• Supplement Date Received by Manufacturer: 06/07/2024; 07/09/2024
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 06/26/2024; 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2022
• 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: Prefer Not To Disclose