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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 470026-62
Device Problem Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/16/2020
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the zero degree endoscope instrument and performed a device evaluation. The customer reported complaint was confirmed but not replicated. Failure analysis discovered that the attached endoscope adapter (aea) retaining ring and screws were missing. Severe damage was found on the cable jacket. Also, errors 45310, 48216, 48221, 45314, 48217, 48225, and 48229 were found in the log. A review of the site's complaint history does not show any additional complaints related to this product. No images or videos were shared for the event. A review of the system logs revealed that the endoscope was last used successfully on (b)(6) 2020. The endoscope was not used on the event date of (b)(6) 2020 which supports the report that the issue was identified prior to the start of the procedure. This complaint is being reported because a dislodged camera adapter could result 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 prior to starting da vinci-assisted prostatectomy surgical procedure, the customer observed degraded image quality and the system reflected an error message. There was no report of patient involvement. The procedure was completed with no reported injury, harm or adverse outcome to the patient.
 
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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 Key10631986
MDR Text Key245069239
Report Number2955842-2020-11042
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeNO
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 09/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470026-62
Device Catalogue Number470026
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/27/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2020
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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