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 Code	Unspecified Tissue Injury (4559)
Date of Event	02/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, the cause of the reported complication cannot be determined.Intuitive surgical, inc.(isi) has not received the stainless steel reprocessing tray lid that was used during this reported event; therefore, failure analysis investigations (fa) has not been performed.An isi clinical development engineer reviewed the provided image and confirmed a protrusion present on the lid of the reprocessing tray and noted that there is a user advisory to inspect the trays prior to use and after use for any defects or damages to mitigate harm.
Event or Problem Description
It was reported that while opening the box in central processing, a metal piece protruding from the lid of a stainless steel reprocessing tray injured the left index finger of a cleaning staff member.The metal protruding part was located around the edge of the lid, near the latch used for locking.The box was being opened for product inspection and the issue was not identified until after the injury occurred.The injury was described as minor, with a small amount of blood that oozed from the finger and was resolved by applying an unspecified disinfectant and a bandage.The tray had been unused, with no report of patient involvement.The site is requesting a replacement.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the stainless steel reprocessing tray for failure analysis evaluation.Failure analysis investigations confirmed the customer reported complaint of sharp edges.The sterilization tray was found to have a metal part protruding near the latch of the tray's lid.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: NONE
• Common Device Name: 8MM ENDOSCOPE STERILIZATION TRAY
• 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: 18862192
• Report Number: 2955842-2024-11939
• Device Sequence Number: 19661774
• Product Code: KCT
• UDI-Device Identifier: 00886874115848
• UDI-Public: (01)00886874115848(10)HU225001
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2024

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: HU225001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/06/2024
• Supplement Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2022
• 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: 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: Male