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

Model Number	370892-03
Medical Device Problem Codes	Crack (1135); Optical Discoloration (2999)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the endoscope involved with this complaint and completed the device evaluation.The endoscope was returned to the original equipment manufacturer (oem) for evaluation.The reported complaint of a dark and pinkish color was confirmed.The endoscope was found to have a cracked distal window resulting in fluid invasion and subsequent major damage to optical components.Due to extensive damage the endoscope must be scrapped.The endoscope was also found to have mechanical damage to the proximal illumination fibers.Fragments of the distal window are missing, or complete window is missing.System log review was performed.Per the review, the following was confirmed: the procedure was performed on system (b)(4) on (b)(6) 2022.No image or video was provided for review.This complaint 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 (distal end).Based on the information provided, there was no report from the customer that a fragment from the instrument fell into the patient during the procedure.While there was no report of harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.
Event or Problem Description
It was reported that prior to starting (pre-anesthesia) a da vinci-assisted surgical procedure, the endo scope exhibited a dark and pinkish color.The procedure was completed using a spare endoscope with no patient harm, adverse outcome, or injury.Intuitive surgical, inc.(isi) made multiple follow-ups attempts to obtain additional information.However, 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: 15331804
• Report Number: 2955842-2022-13778
• Device Sequence Number: 17763946
• Product Code: GCJ
• UDI-Device Identifier: 00886874110201
• UDI-Public: (01)00886874110201
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K101077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/03/2022

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: 07/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 08/31/2022
• 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