inforMED
MalfunctionLRW

SKLAR®

Received Feb 7, 2019 · Event occurred Jan 16, 2019

Report 8314397 · MDR key 8314397

Device

Generic name

Scissors, General, Surgical

Manufacturer

Sklar Corporation

Model number

96-2504C

Lot number

01198405

Product problems

  • Break

Patient

Not reported

  • Injury
  • Injury

Narrative

Description of Event or Problem

RN REPORTED A NEW STERILE PACKAGE OF IRIS SCISSORS WAS OPENED AND SCISSORS IMMEDIATELY BROKE CAUSING THE NURSE TO SUSTAIN A PUNCTURE. THERE WAS NO SERIOUS HARM TO THE NURSE OR THE PATIENT. AN EMPLOYEE INJURY FORM WAS COMPLETED AND THE SCISSORS ARE BEING RETURNED TO THE MANUFACTURER BY THE NURSING UNIT. MANUFACTURER RESPONSE FOR SCISSORS, GENERAL, SURGICAL, SKLAR® (PER SITE REPORTER). THE NURSING UNIT CONTACTED SKLAR CORP DIRECTLY. A COMPLAINT FILE WAS OPENED AND THE DEVICE WILL BE RETURNED FOR FAILURE ANALYSIS. THE STATUS IS CURRENTLY UNKNOWN, BUT WILL BE SHARED WHEN/IF IT BECOMES AVAILABLE.