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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 Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/01/2021
Event Type  malfunction  
Event Description
It was reported that during a da vinci-assisted surgical procedure, the 0-degree endoscope had a piece that popped off. The procedure was completed with no reported injury. Intuitive surgical, inc. (isi) made multiple follow-up attempts to obtain additional information. However, no further details have been received as of the date of this report.
 
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the 0-degree endoscope involved with this complaint and completed the device evaluation. Failure analysis (fa) replicated/ confirmed the customer reported complaint. The endoscope had the dislodged endoscope adapter (aea) retaining ring or screws and the root cause of this failure was due to manufacturing. The endoscope had the cable integrity (visual damage) at zone b. A review of the endoscope logs associated with this event has been performed. Per logs, the endoscope (470057-08/936998) was last used on (b)(6) 2021 on system (b)(4). The endoscope had 1950 uses remaining after the last procedural use. A review of the site's complaint history does not show any additional complaints related to this product. No image or video was provided for review. This complaint is being reported due to the following conclusion: during failure analysis testing, the xi endoscope was found to have dislodged camera instrument adapter (aea) component with no evidence of mishandling or misuse. A dislodged camera adapter and/or missing retaining ring 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. Follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable. The expiration date is not applicable. The product is not implantable. It is unknown if the initial reporter submitted a report to the fda.
 
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Brand NameNONE
Type of DeviceENDOSCOPE 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 Key13102336
MDR Text Key286747334
Report Number2955842-2021-11826
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 12/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470057-08
Device Catalogue Number470057
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/17/2021
Date Manufacturer Received12/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/28/2021
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 Treatment Data
Date Received: 12/28/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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