• 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 ENDOWRIST MONOPOLAR CURVED SCISSORS

  • 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 ENDOWRIST MONOPOLAR CURVED SCISSORS Back to Search Results
Model Number 470179-19
Device Problems Crack (1135); Scratched Material (3020); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/23/2021
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) has not received the monopolar curved scissors (mcs) tip cover accessory for evaluation. The mcs instrument has been received, but evaluation has not been completed. Therefore, the root cause of the customer reported failure mode has not been determined. A follow-up mdr will be submitted following the completion of evaluation and if additional information is received. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. No image/photo was provided. The mcs instrument and the mcs tip cover accessory were not used on the patient because the issue was identified prior to use. Therefore, there is no log information available for the instrument. The mcs tip cover accessory, when used as intended, provides insulation over a section of the endowrist mcs instrument so that radio frequency (rf) energy is only available at the instrument scissor tips. Per the i&a user manual "it is important to exercise caution when using a energized endowrist mcs instrument to help avoid unintended contact with tissue adjacent to the area to be cauterized. " failure to follow these precautions will result in electrical arcs from the wrist and alternate site burns. This complaint is being reported based on the following conclusion: the mcs tip cover accessory was damaged in the dark gray section, with no evidence or claim of user mishandling/misuse. Although no patient harm occurred, and the instrument was not used on a patient, if this malfunction were to recur, it could cause or contribute to an adverse event.
 
Event Description
It was reported that at the beginning of a da vinci-assisted bladder neck suspension procedure, upon installation of the monopolar curved scissors (mcs) tip cover accessory, the operating room staff noticed that the black sheath covering the instrument was scratched. The instrument was not used on the patient. Another instrument was used to proceed with the case. The procedure was completed with no known impact or patient consequence reported. Intuitive surgical, inc. (isi) followed up with the customer to request additional information and obtained the following details on 30-july-2021. The issue was identified at the beginning of the procedure following the installation of the mcs tip cover accessory. It was unknown whether the installation tool was used. There was no exposed wire, and no signs of thermal damage. To avoid any risk of arcing, the instrument was not used on the patient. No image or video was available for review.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameENDOWRIST
Type of DeviceMONOPOLAR CURVED SCISSORS
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
david wang
3410 central expressway
santa clara, CA 
4085232100
MDR Report Key12352152
MDR Text Key267626717
Report Number2955842-2021-10974
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 07/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470179-19
Device Catalogue Number470179
Device Lot NumberN12201110 0673
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/20/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/23/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 08/22/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
-
-