MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; PERMANENT CAUTERY HOOK

Model Number	420183-15
Medical Device Problem Codes	Unintended System Motion (1430); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The permanent cautery hook was analyzed and found to have a broken distal pitch cable at the clevis hub.The broken cable segment that contains the crimp was still installed in the clevis.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.Additionally, when the instrument was installed on an in-house system and driven, the instrument exhibited imprecise motion in the pitch direction.The grip tips moved in the direction commanded, however a lag or delay in the motion was observed.The instrument was found to have indentation on the monopolar yaw pulley.The indentation was found at the pulley near the broken pitch cable.The instrument was found to have damage of the conductor wire¿s insulation at the proximal clevis.There was not material missing and the conductor wires were not exposed.The conductor wire insulation was damaged, but the wire was not torn or fully broken.The instrument passed the electrical continuity test.Components adjacent to the damaged wire insulation show damage which may indicate potential mishandling.The distal idler pulley near the conductor wire found with multiple indentations which likely cause the damage of the conductor wire insulation.The instrument was found to have multiple indentations on the edge of the distal idler pulleys.There were no pieces missing.Grip cables/other components adjacent to this indented pulley show damage which may indicate potential mishandling.The conductor wire-monopolar had a damaged insulation.The instrument was found to have a bent banana plug at the back end of the housing.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, when performing a rotational movement to start the cut, the permanent cautery hook (pch) presented resistance to rotation, making the cutting amplitude difficult.The procedure was completed with no reported injury.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
The permanent cautery hook instrument was transferred to the advance failure analysis (afa) team for additional investigations.Afa confirmed initial failure analysis findings.The instrument was found to have an indentation to the yaw pulley.No material appeared to be missing.

• Brand Name: ENDOWRIST
• Common Device Name: PERMANENT CAUTERY HOOK
• 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: 19317426
• Report Number: 2955842-2024-14620
• Device Sequence Number: 20416916
• Product Code: NAY
• UDI-Device Identifier: 00886874111536
• UDI-Public: (01)00886874111536(10)K10221002
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2024

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: 420183-15
• Device Catalogue Number: 420183
• Device Lot Number: K10221002 582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2022
• 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