ACCULAN 3TI DERMATOME
Received Mar 27, 2015
Report 2916714-2015-00255 · MDR key 4649581
Device
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
COUNTRY OF COMPLAINT: (B)(6). CUSTOMER REPORTS THAT THE THICKNESS OF TH ESKIN IS DIFFERENT AT THE SETUP OF 0.1 MILLIMETER.
Additional Manufacturer Narrative
MANUFACTURING SITE EVALUATION: THE DERMATOME WAS FIRST MANUFACTURED AS A REGULAR ARTICLE GA670, HOWEVER, PER REQUEST OF CUSTOMER, THE REGULAR ARTICLE WAS ADAPTED TO THE S-VARIANT. THE CONVERSION WAS PERFORMED BY AESCULAP TECHNICAL SERVICE (ATS). THE FUNCTIONAL INSPECTION OF THE RECEIVED DEVICE DID NOT INDICATE A MALFUNCTION. THE CUT TRANSPLANT WAS WITHOUT ANY ABNORMALITIES. DURING THE FURTHER INSPECTION USING A GAUGE, IT WAS DETECTED THAT THE ANGLE OF THE CUTTING SETUP WAS INCORRECT. WITH INSERTED GAUGE, THE LEVEL TO ADAPT THE CUTTING THICKNESS SHOULD BE ABLE TO BE TURNED TO POSITION 3. HOWEVER, THE LEVER TO ADAPT THE CUTTING THICKNESS OF THIS DEVICE COULD BE TURNED TO POSITION 6. THIS INDICATES THAT THE CUTTING ANGLE IS INCORRECT. THE CONVERSION OF THE PRODUCT WAS PERFORMED IN JANUARY 2015 BY ATS DEPARTMENT. AS THIS COMPLAINT WAS SUBMITTED IN CLOSE "PROXIMATELY" TO THE CONVERSION, IT IS LIKELY THAT THE SETUP OFF THE PRODUCT WAS INCORRECT. AS THE NATURAL SKIN OF A HUMAN IS NOT AS CONSISTENT AS THE TEST MATERIAL, IT IS POSSIBLE THAT THE FUNCTIONAL TEST DID NOT SHOW THE MALFUNCTION DESCRIBED BY THE CUSTOMER BUT THE CUSTOMER DID EXPERIENCE THE IRREGULAR CUTTING BEHAVIOR AS DESCRIBED, ESPECIALLY AT THE SETUP OF 0.1 MM. BELIEVED TO BE AN ISOLATED INCIDENT, NO CAPA REQUIRED.