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

Model Number	430012-14
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Failure analysis found the primary failure of dislodged coextrusion to be related to the customer reported complaint.The coextrusion component was found to be dislodged at the distal tip.The coextrusion was easily removed from the sheath.There was no missing material.A second sp instrument sheath accessory was analyzed, and failure analysis investigations did not replicate nor confirm the customer reported complaint.The sheath was returned and inspected and found no damage.The coextrusion component was at the distal tip and not loose.There was no complaint against the product to assess the effect of its failure.The third sp instrument sheath accessory was analyzed and failure analysis investigations did not replicate nor confirm the customer reported complaint.Only the coextrusion of the sheath was returned.The coextrusion component of the sheath was dislodged.Failure analysis found the primary failure of lodged coextrusion on the fenestrated bipolar forceps to be related to the customer reported complaint.The instrument was found to have a lodged coextrusion component from an instrument sheath.
Event or Problem Description
The sp instrument sheath was an incidental return included with the fenestrated bipolar forceps which alleges that an instrument sheath would not go on, and another was found with a loose rubber ring.There was no alleged malfunction reported against this accessory.
Additional Manufacturer Narrative
Advanced failure analysis (fa) was completed on the instrument sheath.Initial fa was confirmed.The instrument sheath exhibited a dislodged distal coextrusion.The dislodged distal coextrusion did not exhibit any obvious surface damage, and the sheath's distal end did not appear to exhibit any tearing.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: NONE
• Common Device Name: INSTRUMENT SHEATH
• 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: 18577573
• Report Number: 2955842-2024-10648
• Device Sequence Number: 21122937
• Product Code: NAY
• UDI-Device Identifier: 30886874114347
• UDI-Public: (01)30886874114347(10)NA
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2024

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: 430012-14
• Device Catalogue Number: 430012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/08/2024
• Supplement Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 01/25/2024
• Supplement Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2019
• 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: Unknown