MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; ENDOSCOPE

Model Number	470027-64
Medical Device Problem Code	Image Orientation Incorrect (1305)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported event.The fse checked the system and verified that the image on the endoscope would not rotate.The endoscope would rotate via the surgeon side console (ssc), but its orientation did not change and remained flipped.The fse removed the endoscope from the universal surgical manipulator (usm) and rotated its base until the correct orientation (30 up or 30 down) was displayed on the screen.The clutch button on the usm was pressed to cancel the guided tool change (gtc) feature.The endoscope was re-installed onto the usm and problem was resolved.The system was tested and verified as ready for use.The endoscope involved in this complaint has not been received and/or tested by failure analysis as of the date of this report.If the product is received and evaluated, a supplemental mdr will be submitted.The probable root cause of reported issue may be attributed to improper user setup, specifically related to the endoscope installation on the arm.The issue was resolved by reseating the endoscope and pressing the instrument clutch to cancel the gtc feature.
Event or Problem Description
It was reported that during a da vinci assisted radical prostatectomy without lymphadenectomy surgical procedure, the customer was trying to rotate the endoscope, but the image would not rotate.The customer tried re-installing the endoscope and power cycling the system but with no improvement.An intuitive surgical inc., (isi) technical support engineer (tse) guided the customer to check if the hash mark and touchscreen endoscope degree mark were aligned.The customer stated that the endoscope would rotate when its orientation was changed from the surgeon side console (ssc), but the image did not change.The customer then manually rotated the endoscope orientation and continued with the procedure as planned.There was no reported injury.

• Brand Name: NONE
• Common Device Name: ENDOSCOPE
• 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: 23608323
• Report Number: 2955842-2025-45743
• Device Sequence Number: 9258920
• Product Code: NAY
• UDI-Device Identifier: 00886874112212
• UDI-Public: (01)00886874112212
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K171426
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/20/2025

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: 470027-64
• Device Catalogue Number: 470027
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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