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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 470027-65
Device Problems Component Missing (2306); Device Dislodged or Dislocated (2923)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/14/2020
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the 30-degree endoscope involved with this complaint and completed the device evaluation. Failure analysis (fa) investigation confirmed and replicated the reported complaint. The 30-endosocpe had no issues with either image, and passed the endoscope diagnostic test (edt). It was noted the endoscope was missing the endoscope adapter retaining screws. Based on the additional information obtained from failure analysis investigations, this event is being reported due to the following conclusion: the endoscope was missing the endoscope adapter retaining screws. While there was no report of any patient harm, adverse outcome or injury, recurrence of the reported failure mode could cause or contribute to an adverse event. A review of the site's complaint history does not reveal any related or duplicate complaints involving this product. A log review was conducted, which resulted in the following findings: the logs show the customer last used the endoscope part# 470027-65 serial# (b)(4) on (b)(6) 2020 during a distal pancreatectomy procedure on system (b)(4). The endoscope had 1840 lives remaining. This last usage of the device was before the reported event date, indicating that the device did not pass recognition or the issue was identified before installation on the reported event date. A review of the site's system logs for the reported procedure date was conducted. Investigation revealed there were no related system errors to have occurred during the surgical procedure that would have likely caused or contributed to the reported complaint.
 
Event Description
It was reported that after a da vinci-assisted surgical procedure, a screw from the bottom of the endoscope came out. There was no reported injury or harm. Intuitive surgical, inc. (isi) followed up with the surgical coordinator and obtained the following additional information: the surgical coordinator confirmed the screw fell off on 14-dec-2020 after the procedure had been completed. The endoscope was inspected prior to use with no damage observed. It was noted the procedure was a colon case. The returning endoscope was used during the case with no issue. It was noted that no fragments fell into the patient. No video/image was available for review. The procedure was completed robotically with no patient injury or harm.
 
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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 Key11183369
MDR Text Key245730638
Report Number2955842-2021-10054
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
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 12/31/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470027-65
Device Catalogue Number470027
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/22/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/31/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/21/2020
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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