MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; PERMANENT CAUTERY SPATULA

Model Number	420184-14
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted myomectomy surgical procedure, the permanent cautery spatula instrument had a broken cable.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was inspected prior to use with no issue.The surgeon was dissecting when the issue occurred.The issue was not resolved to opening/closing of the grips, left/right (yaw) motion of the grips, or up/down (pitch) motion of the wrist.One cable was visibly protruding from the distal end of the instrument.The protruding cable was not the one that controls opening/closing of the jaws or that controls up/down motion of the wrist.The silver cable was broken.There was no loss of cautery or sign of thermal damage.The instrument did not collide with any other instrument or tool during the procedure.No fragment fell into the patient.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The permanent cautery spatula (pcs) instrument was analyzed and found to have a broken pitch cable at the proximal clevis hole.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.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.Review of the provided image is consistent with the alleged complaint: a broken pitch cable was observed.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: PERMANENT CAUTERY SPATULA
• 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: 18984618
• Report Number: 2955842-2024-12833
• Device Sequence Number: 11486591
• Product Code: NAY
• UDI-Device Identifier: 00886874111543
• UDI-Public: (01)00886874111543(10)K10220802
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/28/2024

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: 420184-14
• Device Catalogue Number: 420184
• Device Lot Number: K10220802 046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2022
• 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: Female