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

Model Number	370890-06
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the 0 degree endoscope instrument and performed a device evaluation.Failure analysis confirmed the initial complaint that the endoscope was not recognized.Fragments of adhesive of the distal window were also missing.A review of the instrument log for the device associated with this event was performed, however, the event details could not be confirmed.Based on the information provided at this time, this complaint is being reported due to the following conclusion: failure analysis acknowledged that a fragment was missing from a portion of the device that enters the patient.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 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
It was reported that prior to starting, pre-anesthesia, a da vinci assisted surgical procedure, the endoscope was not recognized.There was no reported injury.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) obtained the following information from the customer about the complaint: "the instrument was noted to be damaged before being used in the patient.There was no observation of fallen fragments.Patient did not come back to hospital for complications linked to fragments.".

• 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: 13575940
• Report Number: 2955842-2022-10318
• Device Sequence Number: 4725595
• Product Code: NAY
• UDI-Device Identifier: 00886874110188
• UDI-Public: (01)00886874110188
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 01/27/2022

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: 370890-06
• Device Catalogue Number: 370890
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2022
• Supplement Date Received by Manufacturer: 03/01/2022
• Initial Report FDA Received Date: 02/22/2022
• Supplement Report FDA Received Date: 03/31/2022
• 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: 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 Age: 82 YR
• Patient Sex: Male
• Patient Weight: 68 KG