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

Model Number	430020-10
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The sheath accessory was returned to isi for evaluation with no reported issue.An investigation has been completed.The sheath was returned still installed on the endoscope.Visual inspection of the sheath found it to be damaged.Multiple tears measuring approximately 0.77 mm x 4.91 mm were found along the length of the sheath.There was no material missing as a result.The root cause of this failure is attributed to user.
Additional Manufacturer Narrative
The sheath accessory was returned to isi for evaluation with no reported issue.An investigation has been completed.The sheath was returned still installed on the endoscope.Visual inspection of the sheath found it to be damaged.Multiple tears measuring approximately 0.77 mm x 4.91 mm were found along the length of the sheath.There was no material missing as a result.The firefly endoscope was reported under mfr report number 2955842-2025-47193.

• Brand Name: NONE
• Common Device Name: CAMERA 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: 23784269
• Report Number: 2955842-2025-48371
• Device Sequence Number: 18671114
• Product Code: NAY
• UDI-Device Identifier: 10886874114350
• UDI-Public: (01)10886874114350(10)NA
• 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: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/11/2025

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: 12/09/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 12/11/2025
• 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