ACCULAN 4 DERMATOME 0.1 MM

Additional Manufacturer Narrative

INVESTIGATION RESULTS: CHECKING THE CUTTING GAP ACCORDING TO THE TEST SPECIFICATION REVEALED A DIFFERENCE OF 0.02 MM FROM THE LEFT TO THE RIGHT SIDE. NO FALLING DAMAGE COULD BE DETECTED. BATCH HISTORY REVIEW: THERE ARE NO SIMILAR COMPLAINTS AGAINST THE SAME LOT NUMBER(S) WITH THIS ERROR PATTERN. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON - ADVERSE EVENT (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS ADVERSE EVENT WAS BASED ON THE PATIENT HARM, ADDITIONAL MEDICAL INTERVENTION. CONCLUSION/PREVENTIVE MEASURES: ON THE BASIS OF THE INVESTIGATION RESULTS, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE DEVIATION COMPLAINED BY THE CUSTOMER CAN BE CONFIRMED; AND THE PRODUCT HAD BEEN REPAIRED BY AESCULAP TECHNICAL SERVICE (ATS) ACCORDING TO RECORDS. THERE IS NO INDICATION FOR A MATERIAL DEFECT OR MANUFACTURING FAILURE. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT REQUIRED.

Additional Manufacturer Narrative

MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH GA341 - ACCULAN 4 DERMATOME 0.1MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE SKIN WAS HARVESTED UNEVENLY. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON - ADVERSE EVENT (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS ADVERSE EVENT WAS BASED ON THE PATIENT HARM, ADDITIONAL MEDICAL INTERVENTION. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE ADVERSE EVENT IS FILED UNDER AESCULAP AG REFERENCE NO. (B)(4).