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

Model Number	370892-03
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the endoscope and completed its investigation.Failure analysis (fa) received the scope with mechanical damage to the distal window assembly hermetic seal resulting in fluid invasion and subsequent major damage to optical components.Fragments of adhesive of the distal window are missing.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.Urthermore, verification of the event details cannot be performed via system logs due to lack of event information.Based on the information obtained from failure analysis investigations this is considered a reportable event due to the following conclusion: failure analysis acknowledges that a fragment was missing from a portion of the device that enters the patient.There was no report from the customer that a fragment from the device fell into the patient during a procedure.While there was no report of harm or injury to the patient and no report of fragments falling into the patient, the reported failure mode could likely cause or contribute to an adverse event if the fragment(s) did fall into the patient.
Event or Problem Description
The endoscope was returned with no reported complaint.There was no report of patient involvement.Intuitive surgical, inc.(isi) made several attempts to obtain additional information from the customer, but no further details have been received as of the date of this report.

• Brand Name: NONE
• Common Device Name: ENDOSCOPE, FIREFLY
• 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: 13702226
• Report Number: 2955842-2022-10544
• Device Sequence Number: 6362244
• Product Code: NAY
• UDI-Device Identifier: 00886874110201
• UDI-Public: (01)00886874110201
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 02/09/2022

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: 370892-03
• Device Catalogue Number: 370892
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 03/09/2022
• 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: Unknown
• 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