MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; 8MM ENDOSCOPE STERILIZATION TRAY

Model Number	400498-05
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Tissue Injury (4559)
Date of Event	09/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during central processing, while placing an endoscope into a stainless-steel reprocessing tray, a burr on the underside of the tray cut a staff member¿s finger, causing bleeding.It is unknown how much bleeding occurred; however, the bleeding was resolved by applying a band aid.The tray had been in circulation prior to the reported event; and to prevent a recurrence of the event, the burr was filed off the tray.
Additional Manufacturer Narrative
Based on the information provided, the cause of the reported complication cannot be determined.Intuitive surgical, inc (isi) did not receive the reprocessing tray that was used during this reported event; therefore, failure analysis investigations could not be performed.

• Brand Name: NONE
• Common Device Name: 8MM ENDOSCOPE STERILIZATION TRAY
• 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: 20902088
• Report Number: 2955842-2024-22630
• Device Sequence Number: 9032476
• Product Code: KCT
• UDI-Device Identifier: 00886874115848
• UDI-Public: (01)00886874115848(10)HU221601
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K183139
• 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): 11/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 400498-05
• Device Catalogue Number: 400498
• Device Lot Number: HU221601
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Prefer Not To Disclose