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

MAUDE Adverse Event Report: JUSTRIGHT SURGICAL, LLC JUSTRIGHT 5MM STAPLER STAPLER, SURGICAL

  • 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
 

JUSTRIGHT SURGICAL, LLC JUSTRIGHT 5MM STAPLER STAPLER, SURGICAL Back to Search Results
Model Number JR-ST25-2.0
Device Problem Difficult to Open or Close (2921)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/10/2020
Event Type  Malfunction  
Event Description

Stapler fired and it did not close completely on the appendix. The stapler also did not open correctly making it hard to remove the stapler from the patient. All staples were removed.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameJUSTRIGHT 5MM STAPLER
Type of DeviceSTAPLER, SURGICAL
Manufacturer (Section D)
JUSTRIGHT SURGICAL, LLC
331 s. 104th street suite 200
louisville CO 80027
MDR Report Key9915893
MDR Text Key186141250
Report Number9915893
Device Sequence Number1
Product Code GAG
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 03/23/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/02/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberJR-ST25-2.0
Device Catalogue NumberJR-ST25-2.0
Device LOT Number75K10506
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/23/2020
Event Location Hospital
Date Report TO Manufacturer04/02/2020
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? No
Type of Device Usage

-
-