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

Model Number	430012-14
Medical Device Problem Code	No Apparent Adverse Event (3189)
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
Intuitive surgical, inc.(isi) received a sp instrument sheath accessory as an discrepant return material authorization (rma).There was no alleged malfunction reported against this product.The coextrusion component of the sheath was dislodged and as a result was stuck on fenestrated bipolar forceps.There was no complaint against the product to assess the effect of its failure.
Event or Problem Description
The sp instrument sheath was an incidental return.There was no issue reported for this product.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
Additional information from advanced failure analysis (fa) : initial fa was confirmed.The instrument's proximal clevis exhibited a lodged component.Specifically, the lodged component appeared to be a distal coextrusion from an instrument sheath.The coextrusion appeared to be firmly attached to the distal end of the instrument, and did not appear to be easily removed without cutting.The coextrusion's internal white material appeared to exhibit signs of being autoclaved.The sp i&a manual section 3.4 postoperative instructions, instrument sheath removal subsection step 2 has the following note: "if needed, pinch the distal tip and gently twist and push to remove it from the instrument shaft.Sterile gauze may be used to more firmly grasp the sheath while twisting.The goal of the quoted step is to disengage the sheath's distal ring from the instrument's distal end, and if the step is not performed the sheath's distal coextrusion ring can get stuck and remain on the instrument's distal end after removing the rest of the sheath, due to the distal ring being torn from the sheath during the action of removing the sheath.Only the instrument with the lodged component was returned, and the sheath which the coextrusion originated did not appear to have been returned.Since the sheath was not returned, it was not determinable if the sheath had a manufacturing defect.

• 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: 18548608
• Report Number: 2955842-2024-10532
• Device Sequence Number: 15380619
• 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
• Initial Reporter Occupation: Other Health Care 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
• Is the Reporter a Health Professional?: Yes
• 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: 01/20/2024
• 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