Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 Problems Material Twisted/Bent (2981); Migration (4003)
Patient Problems Abdominal Pain (1685); Inflammation (1932); Obstruction/Occlusion (2422)
Event Date 12/03/2018
Event Type  Injury  
Event Description
Young child patient underwent appendectomy using the stapler.By surgeon report after the event, the operation was performed without difficulty or complications.The patient was discharged home, but brought back several days later with acute abdominal pain.A ct scan demonstrated bowel involvement at the surgical site, and the patient was returned to the operating room for exploration.The surgeon discovered that a staple used previously had bent and migrated in such a way as to cause inflammation and obstruction.The staple was removed, and the bowel repaired with no further complications.A resection was not required, and the child subsequently improved.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
JUSTRIGHT 5MM STAPLER
Type of Device
STAPLER, SURGICAL
Manufacturer (Section D)
JUSTRIGHT SURGICAL, LLC
6325 gunpark drive
boulder CO 80301
MDR Report Key8154483
MDR Text Key130037113
Report Number8154483
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 12/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberJR-ST25-2.0
Device Catalogue NumberJR-ST25-2.0
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/11/2018
Event Location Hospital
Date Report to Manufacturer12/12/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/12/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention;
Patient Age1825 DA
-
-