MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SP; CAMERA, 0°

Model Number	430077-05
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has issued a return material authorization (rma) to have the device returned.However, isi has not received the endoscope involved with the alleged issue to perform failure analysis.Additional information is being gathered to determine the contribution of the device to the customer reported issue.
Event or Problem Description
It was reported that during central processing, the sp endoscope firefly had distal joint crushed inward.There was no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: patient was not harmed.There was no delay in case and backup was available.No further information was available.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The endoscope firefly was analyzed and found to have shaft mechanical damage.The distal main tube was found to be bent outward.Despite the damage on the distal main tube, the endoscope was still fully functional.Although the shaft mechanical was damaged, the qap (quality assurance procedure) could still be performed on the in-house system.Functional tests were performed and passed.Stereo calibration, endoscope focus test and color recognition was performed and passed.Images were clear, dewarped and not grainy.No noise or motion blur was seen.The buttons were fully functional and moved intuitively.First and second edt testing passed.Review of logs showed qty 5 of error 48221 (communications error) and qty 1 of error 48216 (temperature sensor failure), both were not replicated in house.Leak tests were performed and passed.Additional observation(s) not reported by site: the endoscope was found to be corroded/contaminated.The housing was removed and found corrosion/contamination on the input disk/cables.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) received the sp endoscope firefly for failure analysis investigation.The endoscope was analyzed and found to have the distal tip inspected.The shaft mechanical damage was found.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: ENDOWRIST SP
• Common Device Name: CAMERA, 0°
• 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: 21991295
• Report Number: 2955842-2025-19870
• Device Sequence Number: 8479938
• Product Code: IZI
• UDI-Device Identifier: 00886874122228
• UDI-Public: (01)00886874122228
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K212101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/01/2025

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: 430077-05
• Device Catalogue Number: 430077
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2025
• Supplement Date Received by Manufacturer: 06/06/2025; 08/19/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 07/02/2025; 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2024
• 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.
• Patient Sex: Unknown