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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI ENDOSCOPE

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INTUITIVE SURGICAL, INC DA VINCI ENDOSCOPE Back to Search Results
Model Number 470027-64
Device Problem Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/20/2020
Event Type  malfunction  
Manufacturer Narrative
Isi has not received the product involved with this complaint. If the product is received or if additional information is obtained, a follow-up mdr will be submitted. A review of the instrument log for the 30 degree endoscope associated with this event confirmed that the endoscope was last used on (b)(6) 2020 on system sk2737. Per logs, the endoscope has 1935 uses remaining. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. No image or video clip for the reported event was submitted for review. The da vinci x/xi endoscope is intended to provide stereoscopic visualization of tissue and instruments when performing procedures with the da vinci system. Based on the information provided at this time, this complaint is being reported because: it was alleged that an unspecified ring came off of an xi endoscope. An xi endoscope with a missing attached endoscope adapter (aea) ring could result in poor camera control, which could result in unintuitive motion and subsequent tissue damage. While there was no report of patient harm or injury to a 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 during central processing, a ring on top of the where the green light is located came off of the 30 degree endoscope. There was no report of patient involvement. Intuitive surgical, inc. (isi) followed up with the initial reporter and obtained the following additional information: no issues were experienced with the endoscope during procedure. The customer could not provide the patient demographic information nor information about the patient's medical history and relevant tests.
 
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Brand NameDA VINCI
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 Key10849572
MDR Text Key219536298
Report Number2955842-2020-11208
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 health professional,other
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 10/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470027-64
Device Catalogue Number470027
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/17/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/05/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/12/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

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