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

Model Number	372010-02
Medical Device Problem Codes	Break (1069); Poor Quality Image (1408); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to the start of a da vinci-assisted total benign hysterectomy surgical procedure, the 8.5mm 0 degree endoscope had cloudy vision in both eyes.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the endoscope was inspected prior to use.The technician had noticed the problem with the scope during calibration and prior to patient arriving to operating room, scope was removed from the sterile field and taken from the operating room prior to start of procedure.No fragment fell into the patient.The procedure was completed with a backup endoscope.There was no patient injury due to the issue.No images or patient demographics available.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the 0 degree endoscope instrument involved with this complaint and completed the device evaluation.Failure analysis investigations confirmed the reported complaint.The endoscope was received with missing distal window resulting in fluid invasion and subsequent major damage to its optical components.The complete window was missing.There were fragments of adhesive of the distal window missing.

• 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: 16883297
• Report Number: 2955842-2023-12639
• Device Sequence Number: 5829943
• Product Code: NAY
• UDI-Device Identifier: 00886874110447
• UDI-Public: (01)00886874110447
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K101077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/18/2022

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: 372010-02
• Device Catalogue Number: 372010
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 05/06/2023
• 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: Unknown