KNIFE HANDLE 3

Additional Manufacturer Narrative

(B)(4). DR WAS REVIEWED FOR NOTIFICATIONS PERTAINING TO INCOMING INSPECTION, STOCK CHECKS, AND PRODUCT RETURNS. THERE IS A KNOWN ISSUE WITH LOTS D6-F6. EXISTING STOCK IN ON S-BLOCK PENDING CORRECTIVE ACTION. THE DEVICE WAS FUNCTIONALLY TEST WITH A MILTEX BLADE IN ACCORDANCE WITH INCOMING INSPECTION REQUIREMENTS. ONE SAMPLE 352950 WAS RECEIVED FOR INVESTIGATION. LOT D6. NO VISUAL CONCERNS WERE NOTED. THE DEVICE DOES NOT CONFORM TO DIMENSIONAL REQUIREMENTS. THE DEVICE WAS FUNCTIONALLY TESTED WITH A MILTEX BLADE IN ACCORDANCE WITH INCOMING INSPECTION REQUIREMENTS. THIS IS A KNOWN ISSUE WITH MULTIPLE CONFIRMED COMPLAINTS. DHR WAS REVIEWED FOR NOTIFICATIONS PERTAINING TO INCOMING INSPECTION, STOCK CHECKS, AND PRODUCT RETURNS. THERE IS KNOWN ISSUE WITH LOTS D6-F6. EXISTING STOCK IN ON S-BLOCK PENDING CORRECTIVE ACTION. CORRECTIVE ACTION IS BEING DETERMINED. EXISTING STOCK OF THE AFFECTED LOTS HAVE BEEN PLACED ON S-BLOCK PENDING RESOLUTION.

Description of Event or Problem

A DIFFERENT BRAND SCALPEL BLADE DOES NOT FIT THE TELEFLEX #3 KNIFE HANDLE. THERE WAS NO PERSONNEL OR PATIENT INJURY.

Additional Manufacturer Narrative

(B)(4). MDR REPORT 3011137372-2017-00040 HAS ERRONEOUS INFORMATION THEREFORE IT IS BEING RETRACTED BASED ON THE FOLLOWING ADDITIONAL INFORMATION UPDATE: THE REPORTING NURSE STATED THAT THERE WAS NO ATTEMPT TO USE THE DEVICE BECAUSE THE BLADE WOULD NOT FIT ON THE KNIFE HANDLE. THERE WAS NO PATIENT INVOLVEMENT AND NO STAFF INJURY.

Additional Manufacturer Narrative

(B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION AT THIS TIME. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

Description of Event or Problem

A DIFFERENT BRAND SCALPEL BLADE DOES NOT FIT THE TELEFLEX #3 KNIFE HANDLE. THERE WAS NO PERSONNEL OR PATIENT INJURY.