ACCULAN 4 DERMATOME 0.1MM

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 THE PRODUCT GA341 - ACCULAN 4 DERMATOME 0.1MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE SKIN WAS HARVESTED UNEVENLY. AN UNSPECIFIED MEDICAL INTERVENTION WAS PERFORMED. THE PRODUCT WAS THEN SENT FOR REPAIR, AFTER BEING FOUND IN "POOR" CONDITION. 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 NOR AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AESCULAP AG REFERENCE NO. (B)(4).

Description of Event or Problem

UPDATE: AS THE INITIAL ATTEMPT FOR SKIN HARVEST WAS NOT SUCCESSFUL, THE SURGEON USED OTHER DERMATOME FOR ADDITIONAL HARVESTING OF SKIN.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5: UPDATED DESCRIPTION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: H6 - CODES UPDATED. INVESTIGATION RESULTS: THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE INVESTIGATION WAS BASED UPON HISTORICAL DATA ANALYSIS, AND EVENT DESCRIPTION. BATCH HISTORY REVIEW: A BATCH HISTORY REVIEW WAS NOT PERFORMED, DUE TO REPAIR AND MAINTENANCE ON THE PRODUCT. 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: THE ROOT CAUSE OF THE REPORTED UNEVEN CUTTING BEHAVIOR CANNOT BE CLEARLY DETERMINED WITHOUT ACCESS TO THE AFFECTED PRODUCT. ASYMMETRICAL CUTTING BEHAVIOR IS NOT REPRODUCIBLE WHEN REPAIRS ARE CARRIED OUT PROPERLY IN ACCORDANCE WITH THE CURRENTLY VALID SERVICE MANUALS AND TECHNICAL DRAWINGS. THE CUTTING DEPTH IS INFLUENCED BY THE CUTTING GAP (0.2 MM) AND THE SELECTED CUTTING SETTING. THE CORRECT ADJUSTMENT OF THE CUTTING GAP AND PARALLELISM IS CLEARLY DESCRIBED IN THE SERVICE MANUALS. THE BLADE PROTRUSION IS SET USING A DEFINED GAUGE. IN THIS PROCESS, THE PRODUCT CAN BE ADJUSTED TO A CUTTING DEPTH IN THE RANGE OF 0.3 MM TO 0.4 MM WITHOUT ANY NEGATIVE IMPACT ON CUTTING DEPTH OR CUTTING PERFORMANCE. THE DIFFERENT BLADE PROTRUSION SETTINGS SPECIFIED IN THE SERVICE MANUALS DO NOT AFFECT THE PRODUCT SPECIFICATION. FINAL INSPECTION AND CUTTING TESTS ENSURE THE PROPER FUNCTIONALITY OF THE PRODUCT. THERE IS NO RISK TO PATIENTS, USERS, OR THIRD PARTIES RESULTING FROM THE DIFFERING SETTING VALUES IN THE SERVICE MANUALS. THERE IS NO INDICATION FOR A DESIGN-, MANUFACTURING- AND/OR MATERIAL-RELATED FAILURE. IN THE EVENT THAT THE COMPLAINT SAMPLE WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. DUE TO THE INCONSISTENT INFORMATION REGARDING BLADE PROTRUSION IN THE WORK STEP "SETTING BLADE PROTRUSION," ALL RELEVANT DOCUMENTS (DRAWINGS, WORK INSTRUCTIONS, SERVICE MANUALS) WILL BE REVIEWED, STANDARDIZED, AND HARMONIZED TO ENSURE CONSISTENT AND UNAMBIGUOUS SPECIFICATIONS.