inforMED
MalfunctionFSM

MEDLINE

Received May 1, 2026

Report 3004122598-2026-00007 · MDR key 25059552

Device

Generic name

Remover,staple,skin

Catalog number

DYNJ04059

Product problems

  • Insufficient Device Problem Information

Patient

NA · Unknown

  • Pain

Narrative

Additional Manufacturer Narrative

ACCORDING TO THE FACILITY, THE STAPLER REMOVER THEY HAVE IS "NOT A GOOD ONE." THEY HAVE A HARD TIME CUTTING THE STAPLES OFF THE PATIENTS. THE PATIENT WAS COMPLAINING HOW IT WAS PAINFUL WHEN THEY WERE TRYING TO REMOVE THE STAPLES BECAUSE IT KIND OF CUT INTO THE WOUND. THE FACILITY STATED IT DOES NOT WORK PROPERLY. DUE DILIGENCE HAS BEEN COMPLETED. NO ADDITIONAL DETAILS ARE AVAILABLE RELATED TO THE CUSTOMER REPORTED ISSUE. DESPITE MULTIPLE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE CUSTOMER CONTACT WAS UNABLE OR UNWILLING TO PROVIDE FURTHER INCIDENT DETAILS TO THE MANUFACTURER. THE SAMPLE WAS REQUESTED FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

Description of Event or Problem

ACCORDING TO THE FACILITY, THE STAPLER REMOVER THEY HAVE IS "NOT A GOOD ONE." THEY HAVE A HARD TIME CUTTING THE STAPLES OFF THE PATIENTS. THE PATIENT WAS COMPLAINING HOW IT WAS PAINFUL WHEN THEY WERE TRYING TO REMOVE THE STAPLES BECAUSE IT KIND OF CUT INTO THE WOUND. THE FACILITY STATED IT DOES NOT WORK PROPERLY.