• 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 CADIERE FORCEPS SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

  • 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 CADIERE FORCEPS SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number 471049
Device Problems Break (1069); Material Protrusion/Extrusion (2979)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/16/2021
Event Type  malfunction  
Event Description
While suturing the hernia defect, it was noticed that a wire had broken and was poking out of the wrist of the device. Instrument was replaced with new instrument.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameENDOWRIST CADIERE FORCEPS
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kifer road
sunnyvale CA 94086
MDR Report Key12040226
MDR Text Key257437723
Report Number12040226
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number471049
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/17/2021
Event Location Hospital
Date Report to Manufacturer06/22/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

-
-