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

Model Number	420184-14
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the claim against the product by the customer noting a broken connection cable, an investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) received a da vinci product to perform failure analysis.The permanent cautery spatula instrument was analyzed and found to have a broken pitch cable at the distal end.Failure analysis found the primary failure of the broken pitch cable to be related to the customer reported complaint.The broken cable segment that contains the crimp was still installed in the clevis.Failure analysis investigations found an additional failure related to the customer reported complaint.The permanent cautery spatula was found to have a loose pitch cable at the distal end, that was caused by the broken pitch cable.Blank mdr fields: the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Information for the blank fields in section e1 is not available.Fields g5 and g7 are not applicable.
Event or Problem Description
It was reported that during a da vinci-assisted myomectomy surgical procedure, the connection cable of the permanent cautery spatula instrument was broken.There was no report of any fragments falling inside the patient.The procedure was completed with no reported injury.Evaluation of the returned device found a broken pitch cable at the distal end.Intuitive surgical, inc.(isi) has attempted to obtain additional information related to the reported event.However, as of the date of this report, no additional information has been provided.

• 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: 17560090
• Report Number: 2955842-2023-17780
• Device Sequence Number: 3600216
• Product Code: NAY
• UDI-Device Identifier: 00886874111543
• UDI-Public: (01)00886874111543(10)N10210628
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/19/2023

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: N10210628 539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2021
• 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 Sex: Female