MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; INSTRUMENT SHEATH

Model Number	430012-17
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The sheath was analyzed and was returned with a dislodged distal coextrusion.No material appears to be missing.The coextrusion can become dislodged if the bonding process done in manufacturing is not done properly at the supplier.The complaint was confirmed by failure analysis.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the instrument sheath was not fastening and seemed to be loose.The customer removed it and found that the inner part was torn.There was no report of fragment(s) falling inside the patient.The procedure was completed with another product.

• Brand Name: NONE
• Common Device Name: INSTRUMENT SHEATH
• 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: 20701219
• Report Number: 2955842-2024-21989
• Device Sequence Number: 20479083
• Product Code: NAY
• UDI-Device Identifier: 30886874114347
• UDI-Public: (01)30886874114347(17)260531(10)K10240523
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/24/2024

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: 430012-17
• Device Catalogue Number: 430012
• Device Lot Number: K10240523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 11/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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