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

Model Number	470026-64
Medical Device Problem Code	Optical Distortion (3000)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted benign hysterectomy surgical procedure, one eye of the 8mm endoscope was completely blurry.The procedure was converted to laparoscopic surgery while waiting for another endoscope to be processed for usage.There was no report of patient harm, adverse outcome, or injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was inspected prior to use.There was no other 0-degree scope available at the time of the event.The procedure was converted to laparoscopic surgery with no patient injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the 8mm endoscope involved with this complaint and completed the device evaluation.Failure analysis confirmed the customer reported.Upon inspection, the front (negative) lens detached was found on the right eye.

• 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: 17015863
• Report Number: 2955842-2023-14983
• Device Sequence Number: 12653894
• Product Code: NAY
• UDI-Device Identifier: 00886874112205
• UDI-Public: (01)00886874112205
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/13/2021

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: 05/27/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2021
• 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 Age: 41 YR
• Patient Sex: Female
• Patient Weight: 68 KG