• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI MONOPOLAR CURVED SCISSORS (MCS) TIP

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

INTUITIVE SURGICAL, INC DA VINCI MONOPOLAR CURVED SCISSORS (MCS) TIP Back to Search Results
Model Number 430035-01
Device Problem Material Separation (1562)
Patient Problem Insufficient Information (4580)
Event Date 11/17/2021
Event Type  Injury  
Manufacturer Narrative
Intuitive surgical, inc. (isi) will not be receiving the mcs tip as it was lost. A follow-up mdr will be submitted if additional information is received. Information for the mcs tip accessory does not get captured in the logs, so no log reviews were available. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. No images or videos for the event were available. This complaint is being reported due to the following conclusion: it was alleged during a procedure that the mcs tip came off of the mcs instrument and could not be found. An x-ray was performed and the mcs tip was not seen. The location of the mcs tip and the reason that it came off of the instrument remain unknown. It is unknown if the mcs tip fell inside the patient's anatomy and was retained. Follow-up was attempted, but the missing patient information was either unknown, unavailable, not provided, or not applicable. The expiration date is not applicable. The product is not implantable. The initial reporter submitted a report to the fda.
 
Event Description
It was reported that during a da vinci-assisted radical prostatectomy without lymphadenectomy surgical procedure, the monopolar curved scissors (mcs) tip came off of the mcs instrument and could not be located. An x-ray was performed and the mcs tip was not seen. The instruments were reportedly inspected prior to the procedure and nothing looked out of the ordinary. There was no collision with any other instrument or hard materials during the procedure. It was unknown how long the instrument had been in use when the issue occurred. According to the nurse, she and the surgeon felt that the mcs tip came off because it is not attached to the instrument and should be more secure. She mentioned that the mcs tip was very difficult to install and stated that future designs should have the tip pre-installed. The instrument will not be returned for analysis since there was no instrument issue, and the mcs tip cannot be found to be returned. The patient has not returned due to any post-surgical complications.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDA VINCI
Type of DeviceMONOPOLAR CURVED SCISSORS (MCS) TIP
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 Key12981700
MDR Text Key287254742
Report Number2955842-2021-11727
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K182371
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 11/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number430035-01
Device Catalogue Number430035
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 12/12/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
-
-