MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI; ENDOSCOPE

Model Number	470026-62
Medical Device Problem Code	Misfocusing (1401)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the claim against the product by the customer noting a scope left eye blur, an investigation is in progress to determine the cause of this reported event.Intuitive surgical, inc.(isi) has received the 0-degree endoscope.However, as of the date of this report, the failure analysis evaluation of the device has not been completed.A follow-up mdr will be submitted after evaluation of the device has been completed or if additional information is received.Note: refer to medwatch report (mdr) with patient identifier (b)(6) for mdr submission of the same event reported against the other endoscope.
Event or Problem Description
It was reported that during a da vinci-assisted benign hysterectomy surgical procedure, the customer called an intuitive surgical, inc.(isi) technical support engineer (tse) after docking due to the left eye on a 0-degree endoscope being blurry.The customer tried to troubleshoot by replacing the endoscope, but the image was still blurred.The tse had the customer power cycle and hard cycle the vision side cart (vsc) but the image was still not coming up normally.The tse had the customer verify the image was bad on the vsc as well as on the surgeon side cart (ssc).The surgeon opted to cancel the case.There was no report of patient harm due to this event.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: patient was fine.There were no complications or patient injury post-anesthesia.They just had to wake up the patient as there was no scope to use.
Additional Manufacturer Narrative
Based on the claim against the product by the customer noting an endoscope left eye blur, an investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The endoscope was analyzed and found to have a camera module issue.The camera module exhibited poor focus at 140mm left eye.The endoscope was disassembled, and camera module was visually inspected for damage and/or placed on a diagnostic tester.The camera module exhibited a front (negative) lens detached.Also, the endoscope was visually inspected and manually tested by hand, using a series of movement tests and failed.The endoscope was detected with rattling or noise from the housing and/or detected loose balls from the led windows.A dislodged desiccant ball inside the backend housing was confirmed.Moreover, the endoscope was evaluated and found with a camera instrument adapter defect.The endoscope was placed through friction test using a screening aide to manually rotate the adapter to detect for friction.The camera instrument adapter did not rotate properly and/or noises were heard during testing and confirmed as binding.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.The probable cause of the image issue is typically attributed to damage during use or improper handling.Accidental drops of the endoscope, inadvertent collisions with hard surfaces, or improper cleaning during reprocessing can result in damaged optical components.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: DA VINCI
• 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: 17398901
• Report Number: 2955842-2023-17324
• Device Sequence Number: 7657953
• Product Code: NAY
• UDI-Device Identifier: 00886874112205
• UDI-Public: (01)00886874112205
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2023

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: 470026-62
• Device Catalogue Number: 470026
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/27/2023
• Supplement Date Received by Manufacturer: 07/29/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2017
• 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