MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SINGLE-SITE; CURVED SCISSORS

Model Number	478057-04
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	08/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The single-site curved scissors instrument involved with this event has been received, but the failure analysis testing has not yet been completed as of the date of this report.A follow-up mdr will be submitted when failure analysis has completed their investigation.
Event or Problem Description
It was reported that during central processing, it was discovered that the single-site curved scissors instrument was missing a small, metal circular piece at the end.There was no report of patient involvement.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: there were no reports of the instrument colliding during its last use, nor were there any reports of fragments falling into the patient.The fragment was discovered during central processing.
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 single-site curved scissors instrument was analyzed and it was found that the clevis pin measuring approximately 0.785 x 0.840 on the distal end was visibly missing.The missing pins were not returned with the instrument.The complaint was confirmed by failure analysis.

• Brand Name: SINGLE-SITE
• Common Device Name: CURVED 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: 20142573
• Report Number: 2955842-2024-19038
• Device Sequence Number: 7417656
• Product Code: NAY
• UDI-Device Identifier: 00886874113615
• UDI-Public: (01)00886874113615(11)230405(10)K10230405
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K152448
• 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
• Report Date (Section B): 08/09/2024

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: 478057-04
• Device Catalogue Number: 478057
• Device Lot Number: K10230405 0014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/09/2024
• Supplement Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 09/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2023
• 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