ACCULAN 4 SMALL DRILL
Received May 13, 2023
Report 9610612-2023-00120 · MDR key 16926532
Device
Generic name
Power Systems
Manufacturer
Aesculap AgModel number
GA344Catalog number
GA344
Lot number
52601730
Product problems
- Manufacturing, Packaging or Shipping Problem
- Manufacturing, Packaging or Shipping Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BASED UPON THE INVESTIGATION RESULTS, THE COMPLAINT HAS BEEN REASSESSED AND FOUND TO BE NON-REPORTABLE, AS NO DEFECT WAS FOUND. INVESTIGATION: THE INVESTIGATION WAS CARRIED OUT BY AESCULAP TECHNICAL SERVICES (ATS). A THOROUGH CHECKLIST WAS FOLLOWED AND REVIEW WAS PERFORMED. DEVICE HISTORY REVIEW: SINCE A REPAIR WAS PERFORMED, A REVIEW OF THE DEVICE HISTORY RECORDS IS NOT NECESSARY. CONCLUSION/PREVENTIVE MEASURES: NO DEFECT WAS FOUND, AND THE PRODUCT WAS ACCORDING TO SPECIFICATIONS. POSSIBLY THERE WAS A DEFECT IN ANOTHER COMPONENT OR DURING HANDLING. BASED UPON THE INVESTIGATION RESULTS, NO CAPA IS 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 GA344 - ACCULAN 4 SMALL DRILL. ACCORDING TO THE COMPLAINT DESCRIPTION, THE PRODUCT WAS FOUND TO BE DEFECTIVE DURING THE SURGERY. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).