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

Model Number	430020-10
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although there is no claim against the product, an investigation was completed to determine the cause of the rma.The camera sheath accessory was analyzed and found to be torn.The partially returned sheath measured about 0.513" in length.The rest of the sheath was not returned.There was no complaint against the product to assess the effect of its failure.
Event or Problem Description
The camera sheath accessory was an incidental return included with rma 1505840 which alleges that the firefly camera was out of lives.No allegation was made against this product.Intuitive surgical inc.(isi) followed up with the initial reporter and the following additional information was obtained: there were no reports of fragments falling into the patient when the camera sheath was last used.

• Brand Name: NONE
• Common Device Name: CAMERA 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: 18620454
• Report Number: 2955842-2024-10956
• Device Sequence Number: 2406351
• Product Code: NAY
• UDI-Device Identifier: 10886874114350
• UDI-Public: (01)10886874114350(10)NA
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Report Date (Section B): 01/19/2024

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: 430020-10
• Device Catalogue Number: 430020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2019
• 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