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

Model Number	372010-02
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an internal service activity, an endoscope was returned as non-defective.There was no report of patient involvement.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the 8.5mm 0-degree endoscope and completed the device evaluation.The endoscope was returned with no reported complaint.The endoscope was received 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 were missing.Additional finding included that the endoscope was exposed to a temperature greater than 82°c/179.6°f as shown by internal temperature indicator, resulting in damaged hermetic seals, fluid invasion, and subsequent damage to the complete optical system.The root cause of the findings was attributed to mishandling/misuse.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.Instrument logs for this si endoscope were not available for review.No image or video clip for the reported event was submitted for review.Based on the information obtained from failure analysis investigations, this complaint is considered a reportable event due to the following conclusion: failure analysis acknowledged that a fragment was missing from a portion of the device that is placed inside a patient.Based on the information provided, there was no report from the customer that a fragment from the instrument fell into a 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.

• 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: 13614870
• Report Number: 2955842-2022-10381
• Device Sequence Number: 5024098
• Product Code: GCJ
• UDI-Device Identifier: 00886874110447
• UDI-Public: (01)00886874110447
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/31/2022

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: 01/27/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 02/26/2022
• 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: 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