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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 470056-05
Device Problem Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/15/2020
Event Type  malfunction  
Manufacturer Narrative
Image/video review: no image, or video clip for the reported event was submitted for review. Instrument log review: this endoscope was last used on (b)(6) 2020 on system sl0215 with 1939 uses remaining. Intuitive surgical, inc. (isi) received the endoscope involved with this complaint and completed the device evaluation. Failure analysis confirmed the reported issue. The camera was found to have a cut in zone b of the cable jacket. There were additional findings not reported by site. The camera was found to have several deep scratches on the housing, the retaining ring was missing from the endoscope adapter, and mechanical damage was found on the cable ferrule. Review of the error log found that the scope generated error code (b)(4). This complaint is being reported because the endoscope adapter retaining ring was missing, which could result in poor camera control leading to un-intuitive 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. The product is not implantable; it is unknown if the initial reporter submitted a report to the fda.
 
Event Description
It was reported that after a da vinci-assisted surgical procedure, the endoscope had a tear/cut in the cord. The procedure was completed with no reported injury.
 
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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 Key10796687
MDR Text Key216644283
Report Number2955842-2020-11168
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K191736
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 10/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470056-05
Device Catalogue Number470056
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/06/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/13/2020
Was Device Evaluated by Manufacturer? Yes
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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