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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE ENDOSCOPE

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INTUITIVE SURGICAL, INC NONE ENDOSCOPE Back to Search Results
Model Number 470027-61
Device Problem Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/18/2020
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the parts involved with this complaint and completed the device evaluation. Failure analysis confirmed the customer reported issue. Visual inspection revealed visible holes in the teflon wrap and missing aea retaining ring or screws. The endoscope had optical damage and i-beam cracks. A review of the site's complaint history does not show any additional complaints related to this product. No image or video clip for the reported event was submitted for review. A log review was performed and showed that the endoscope with serial number sf (b)(4) was last used on (b)(6) 2020 on system (b)(4). It had 1906 lives remaining. This complaint is assessed as a reportable event due to the following conclusion: a dislodged camera adapter and/or missing aea results in poor camera control, which could result in unintuitive motion and subsequent tissue damage. While there was no 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 Description
It was reported that after a da vinci-assisted surgical procedure, it was noted that the 30 degree endoscope's housing was broken and damaged physically. The customer reportedly did not know what caused the damage. There was no report of patient involvement or injury. Intuitive surgical, inc. (isi) followed up with customer and obtained the following information: the issue was discovered during the procedure. The endoscope was inspected before use and there was nothing out of the ordinary. The endoscope passed engagement and recognition and was working fine. During the procedure, the surgeon wanted to swap the endoscope from arm 2 to arm 3. When the nurse tried to remove the endoscope from arm 2, she noticed that the housing seemed detached, and she replaced it with a new endoscope. The surgery was completed robotically with no injury. There was no collision of the endoscope with the other instruments and the endoscope was not dropped prior to the issue occurring. The reporter is unable to provide any patient-related information.
 
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Brand NameNONE
Type of DeviceENDOSCOPE
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA 95051
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA 95051
Manufacturer Contact
david wang
3410 central expressway
santa clara, CA 95051
4085232100
MDR Report Key10486204
MDR Text Key233926992
Report Number2955842-2020-10851
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K171426
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial
Report Date 08/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470027-61
Device Catalogue Number470027
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/27/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/22/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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