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

Model Number	372010-02
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The endoscope was returned to the original equipment manufacturer (oem) for evaluation.The customer reported complaint was confirmed.The endoscope was received with a missing distal window resulting in fluid invasion and subsequent major damage to the optical components.Complete window was missing.Fragments of adhesive of the distal window were also missing.There was an additional observation not reported by the site and not related to the reported issue.The endoscope was exposed to a temperature greater than 82c/179.6f as shown by the internal temperature indicator, resulting in damaged hermetic seals, fluid invasion and subsequent damage to complete optical system.
Event or Problem Description
It was reported that during central processing, the endoscope had a poor picture quality and focusing issue.There was no report of patient involvement.

• 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: 16971246
• Report Number: 2955842-2023-13904
• Device Sequence Number: 6480654
• Product Code: GCJ
• UDI-Device Identifier: 00886874110447
• UDI-Public: (01)00886874110447
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/25/2021

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: 372010-02
• Device Catalogue Number: 372010
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 05/21/2023
• 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