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

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION JARIT RETRACTOR, SELF-RETAINING

  • 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
 

INTEGRA LIFESCIENCES CORPORATION JARIT RETRACTOR, SELF-RETAINING Back to Search Results
Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/30/2016
Event Type  malfunction  
Event Description
Surgeon placed grasper in through trocar to use on a laparoscopic cholecystectomy. When surgeon opened grasper to use the working side broke off and fell into abdomen. Piece retrieved, no injury to patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameJARIT
Type of DeviceRETRACTOR, SELF-RETAINING
Manufacturer (Section D)
INTEGRA LIFESCIENCES CORPORATION
4900 charlemar drive
bldg a,
cincinnati, OH 45227
MDR Report Key5614283
MDR Text Key43880722
Report Number5614283
Device Sequence Number1
Product Code PKE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 04/21/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/28/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/21/2016
Event Location Hospital
Date Report to Manufacturer04/21/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-