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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC NONE; ENDOSCOPE PLUS Back to Search Results
Model Number 470057-08
Device Problem Image Orientation Incorrect (1305)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/03/2023
Event Type  malfunction  
Event Description
It was reported that during a da vinci-assisted surgical procedure, the 30-degree endoscope's camera keeps flipping when angled and squeaks when flipped.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the initial reporter stated that, the vision issue did not result in patient injury, and the procedure was completed with a backup endoscope.
 
Manufacturer Narrative
Based on the claim against the product by the customer noting the image on the endoscope flipped an investigation is in progress.Intuitive surgical, inc.(isi) has not received the endoscope involved.Additional information is being gathered to determine the contribution of the device to the customer reported issue.Since the product has not been returned for evaluation, the root cause of the customer reported failure mode could not be determined.A follow-up mdr will be submitted when failure analysis has completed their investigation.This complaint is considered a reportable event due to the following conclusion: it was alleged that the endoscope moved with unintuitive motion/freely with uncontrolled motions.Poor camera control could result in unintuitive motion and subsequent tissue damage.At this time, the root cause of the failure is unknown.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
Refer to h10/h11 for follow-up information.
 
Manufacturer Narrative
Based on the claim against the product by the customer noting keeps flipping when angled and squeaks when flipped, an investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The endoscope was analyzed and found to have damaged attached endoscope adapter (aea) or friction issue, button mechanical damage, desiccant container damage or loose desiccant balls and endoscope bearing friction issue.
 
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Brand Name
NONE
Type of Device
ENDOSCOPE PLUS
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 Key16841367
MDR Text Key314552159
Report Number2955842-2023-12233
Device Sequence Number1
Product Code GCJ
UDI-Device Identifier00886874116555
UDI-Public(01)00886874116555
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,Followup
Report Date 04/04/2023
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
Device Operator Health Professional
Device Model Number470057-08
Device Catalogue Number470057
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Initial Date Manufacturer Received 04/04/2023
Initial Date FDA Received04/30/2023
Supplement Dates Manufacturer Received05/31/2023
Supplement Dates FDA Received06/26/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/17/2021
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
Patient Sequence Number1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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