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

Model Number	470027-62
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted cholecystectomy surgical procedure, the endoscope image was upside down and flipped.The customer had to remove and reseat the endoscope multiple times.The intuitive surgical, inc.(isi) technical support engineer (tse) explained that the issue may have been due to the endoscope being installed at a vertical angle and the system may not have known which angle was down because the endoscope was pointed toward the floor.The tse explained that removing the endoscope and pressing the universal surgical manipulator (usm) clutch button would typically clear out the guided tool change and allow the endoscope to be installed again normally.The tse explained that if the position/angle of the physical endoscope was pointing down, both angle up and angle down may be pointing down.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did not receive the da vinci product with an alleged issue to perform failure analysis.Although the complaint was not confirmed by failure analysis since the product was not returned, the information gathered indicates that the device may have contributed to the customer reported issue.

• 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: 19639088
• Report Number: 2955842-2024-16409
• Device Sequence Number: 8793565
• Product Code: NAY
• UDI-Device Identifier: 00886874112212
• UDI-Public: (01)00886874112212
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K171426
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/07/2024

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: 470027-62
• Device Catalogue Number: 470027
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 06/28/2024
• 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: 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: Prefer Not To Disclose