• 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 FENESTRATED BIPOLAR FORCEPS

  • 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 FENESTRATED BIPOLAR FORCEPS Back to Search Results
Lot Number N11170407 483
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem Foreign Body In Patient (2687)
Event Date 09/25/2017
Event Type  Injury  
Event Description
This pt underwent a robotic laparoscopic total abdominal hysterectomy. During the procedure, it was noted that the tip of the fenestrated bipolar forceps broke off in the pt. The broken off pieces were successfully located and retrieved.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFENESTRATED BIPOLAR FORCEPS
Type of DeviceFENESTRATED BIPOLAR FORCEPS
Manufacturer (Section D)
INTUITIVE SURGICAL
sunnyvale CA 94086
MDR Report Key6968217
MDR Text Key90067698
Report NumberMW5072869
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 10/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot NumberN11170407 483
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/23/2017 Patient Sequence Number: 1
-
-