SAFETY SCALPEL
Received Apr 12, 2017 · Event occurred Mar 16, 2017
Report 1060680-2017-00011 · MDR key 6487207
Device
Product problems
- Mechanical Problem
- Retraction Problem
- Mechanical Problem
- Retraction Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
ROOT CAUSE: A SUPPLIER CORRECTIVE ACTION REPORT (SCAR) WAS ISSUED TO THE MANUFACTURER, S&S SURGICAL. IN ITS RESPONSE, S&S SURGICAL STATED THERE WAS EXTREME VARIATION IN THE STITCH CUTTER BLADES CAUSING IMPROPER ASSEMBLY. THE BLADES ARE MANUFACTURED BY SWANN MORTON. SWANN MORTON IS AWARE THAT THE STITCH CUTTER BLADES HAVE A VARIATION. CORRECTIVE ACTION: IN ITS SCAR RESPONSE, S&S INDICATED A CORRECTIVE ACTION HAS NOT BEEN TAKEN AT THIS TIME. INVESTIGATION SUMMARY AN INTERNAL COMPLAINT (CALL (B)(4)) WAS RECEIVED REPORTING THAT THE BLADE OF A SAFETY SCALPEL (PART NUMBER SM45SCNS) WAS NOT FULLY RETRACTED INTO THE HANDLE THUS CREATING A RISK FOR SERIOUS INJURY. A PHOTOGRAPH OF THE REPORTED INCIDENT WAS RECEIVED. THE PURCHASE ORDER WAS REVIEWED FOR POSSIBLE DISCREPANCIES, NONE WERE DOCUMENTED. THE SCALPEL IS SUPPLIED TO DEROYAL BY S &S SURGICAL. THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST HAS BEEN ISSUED. AS OF THE DATE OF THIS REPORT, THE SCAR IS STILL OPEN. THE 2014-2016 SCAR AND SUPPLIER NOTIFICATION LETTER LOGS WERE REVIEWED FOR SIMILAR COMPLAINTS. SIMILAR COMPLAINTS FOR THE ITEM WERE IDENTIFIED. PREVENTIVE ACTION: S&S STATED IN ITS SCAR RESPONSE THAT A PREVENTIVE ACTION HAS NOT BEEN TAKEN. THE INVESTIGATION IS COMPLETE. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.
Description of Event or Problem
THE SAFETY SCALPEL BLADE IS NOT FULLY RETRACTED WITHIN THE HANDLE, WHICH PRESENTS RISK OF SERIOUS INJURY. ALSO, A LOOSE BLADE WAS FOUND INSIDE ONE OF THE INNER BAGS. THIS WAS FOUND DURING UNPACKING OF THE PRODUCT.
Additional Manufacturer Narrative
INVESTIGATION SUMMARY AN INTERNAL COMPLAINT (B)(4) WAS RECEIVED REPORTING THAT THE BLADE OF A SAFETY SCALPEL (PART NUMBER SM45SCNS) WAS NOT FULLY RETRACTED INTO THE HANDLE THUS CREATING A RISK FOR SERIOUS INJURY. THE SCALPEL IS SUPPLIED TO DEROYAL BY (B)(4). THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST HAS BEEN ISSUED. AS OF THE DATE OF THIS REPORT, THE SCAR IS STILL OPEN. THE INVESTIGATION IS ONGOING. THIS REPORT WILL BE UPDATED WHEN NEW AND CRITICAL INFORMATION IS RECEIVED.
Description of Event or Problem
THE SAFETY SCALPEL BLADE IS NOT FULLY RETRACTED WITHIN THE HANDLE, WHICH PRESENTS RISK OF SERIOUS INJURY. ALSO, A LOOSE BLADE WAS FOUND INSIDE ONE OF THE INNER BAGS. THIS WAS FOUND DURING UNPACKING OF THE PRODUCT.