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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 08/18/2020
Event Type  malfunction  
Manufacturer Narrative
The endoscope involved with this complaint underwent a device evaluation. Failure analysis investigation confirmed the reported complaint. The endoscope was missing the attached endoscope adapter (aea) retaining ring or screws. A review of the submitted image was performed by the isi quality investigations engineer (qie). The qie confirmed the customer was alleging that the aea was dislodged. However, the gap between the adapter and housing is expected. A review of the log for the endoscope associated with this event was performed. Per logs, the endoscope ((b)(4)) was last used on (b)(6) 2020 on system sk0831. The endoscope had 1639 uses remaining. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. Based on the information provided at this time, this complaint is being reported due to the following conclusion: a missing 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. Blank mdr fields: follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable. The expiration date is not applicable. Field: if implanted, give date is not applicable because the product is not implantable. The information for blank fields in initial reporter is not available. Field: if remedial action initiated, check type is not applicable.
 
Event Description
It was reported that out of box, there was a distance between the ¿clamping device¿ and the endoscope head. The gray plastic part to lock the endoscope had too much play and did not lock itself as usual. There was no report of patient involvement. Intuitive surgical, inc. (isi) followed up with the initial reporter on 21-oct-2020 and obtained the following additional information: the issue occurred after unpacking the endoscope, prior to starting the procedure. There was no patient involvement.
 
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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 Key10789477
MDR Text Key214801911
Report Number2955842-2020-11165
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
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 10/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2020
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 Manufacturer09/13/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/12/2020
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

Patient Treatment Data
Date Received: 11/04/2020 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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