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

Model Number	470026-64
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the 8mm endoscope involved with this complaint and completed the device evaluation.Failure analysis investigation confirmed and replicated the customer reported complaint.The endoscope was inspected and fault 45312 was observed on the right eye.The endoscope adapter (aea) was damaged and had a friction issue.
Event or Problem Description
It was reported that during a da vinci-assisted oophorectomy surgical procedure, the surgeon opted to convert the procedure to a laparoscopic procedure, as they had encountered a flashing image with the 8mm endoscope.Troubleshooting was not attempted.When the surgeon tried to see the image without use of the endoscope, they observed the image had some snow/static on the vision side cart (vsc) touch screen.An intuitive surgical, inc.(isi) technical support engineer (tse) recommended hard-cycling the vsc when possible.A review of the system logs performed by the tse reported 45314 faults.The procedure was converted to laparoscopic surgery with no reported injury to the patient.Isi followed up with the initial reporter and obtained the following additional information regarding the reported event: the site's nurse confirmed the procedure was completed successfully using laparoscopy, with no injury to the patient.

• Brand Name: NONE
• Common Device Name: ENDOSCOPE
• 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: 17015859
• Report Number: 2955842-2023-14984
• Device Sequence Number: 7566352
• Product Code: NAY
• UDI-Device Identifier: 00886874112205
• UDI-Public: (01)00886874112205
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/10/2021

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: 470026-64
• Device Catalogue Number: 470026
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/10/2021
• Initial Report FDA Received Date: 05/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Female