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

Model Number	370891-04
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to a da vinci-assisted surgical procedure, the 30-degree endoscope was found to have recognition failure.The same endoscope was able to be used, and 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 issue was identified prior to starting the procedure, so the patient was not involved.There was no report of fragments falling from the device while used within a patient.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the 30-degree endoscope involved with this complaint and completed the device evaluation.Failure analysis investigations confirmed the customer reported complaint " recognition failure." the endoscope was received with non-readable radio frequency identifier (rfid) chip.Rfid chip is not recognized by software.The endoscope had mechanical damage to distal illumination fiber.Fragments of the fiber optic were found to be missing.The root cause of this failure was found to be mishandling/misuse.Verification of the si endoscope product via system logs cannot be performed because si endoscope product details are not captured in the system log.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.The customer provided an image of the endoscope, but the potential damage cannot be seen nor determined based on the image.This complaint is being reported due to the following conclusion: it was identified through failure analysis 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.

• 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: 13703657
• Report Number: 2955842-2022-10545
• Device Sequence Number: 6267959
• Product Code: NAY
• UDI-Device Identifier: 00886874110195
• UDI-Public: (01)00886874110195
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K081137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• 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: 370891-04
• Device Catalogue Number: 370891
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2022
• 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: 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