ACCULAN 3TI DERMATOME
Received Mar 27, 2015
Report 2916714-2015-00256 · MDR key 4649582
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 THE SKIN 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 INVESTIGATION OF THE RECEIVED DERMATOME SHOWED THAT THE MEASURING BEAM PLANE HAS DENTS. A FUNCTIONAL INSPECTION OF THE DERMATOME SHOWED A CORRECT CUTTING BEHAVIOR WITH THE TEST MATERIAL. THE FAILURE DESCRIPTION OF THE CUSTOMER IS THAT ON THE SMALLEST SIZE, THE CUTTING PERFORMANCE IS IRREGULAR. THE DENTS WHICH COULD BE FOUND ON A COMPONENT THAT ARE DIRECTLY LOCATED BEHIND THE PLACE OF THE CUTTING BLADE. THIS MEANS THAT THE SKIN TRANSPLANT GOES RIGHT TO THIS COMPONENT AFTER CUTTING. AT A CUTTING SETUP OF 0.1 MM, THE DENTS CAN NEGATIVELY INFLUENCE THE TRANSPLANT IN CAUSING HOLES OR SIMILAR INSUFFICIENCIES. THE TEST MATERIAL DID NOT SHOW ANY PROBLEMS WHILE CUTTING; HOWEVER, AS THE NATURAL SKIN OF A HUMAN IS NOT AS CONSISTENT AS THE TEST MATERIAL, IT IS THINKABLE THAT THE FUNCTIONAL TEST DID NOT SHOW THE MALFUNCTION DESCRIBED BY THE CUSTOMER. THE PRODUCT WAS DELIVERED TO THE CUSTOMER IN (B)(6) 2015. DUE TO THE ACTUAL MANUFACTURING DATE AND WITHOUT FURTHER KNOWLEDGE ABOUT THE CIRCUMSTANCES OF THE DEFECT, THE EXACT ROOT CAUSE FOR THE DENTS CANNOT BE DETERMINED.