FILTER RETENTION PLATE
Received Oct 19, 2021 · Event occurred Sep 30, 2021
Report 9610612-2021-00671 · MDR key 12657473
Device
Product problems
- Device Difficult to Maintain
- Device Difficult to Maintain
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
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 JK100 - FILTER RETENTION PLATE. ACCORDING TO THE COMPLAINT DESCRIPTION, BLACK PARTICLES WERE DETECTED. THE CUSTOMER FOUND BLACK SPECS INSIDE OF TWO RETRACTOR TRAYS. THIS WAS SUSPECTED TO BE CAUSED BY/FROM THE RETENTION PLATES. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).
Additional Manufacturer Narrative
ADDITIONAL INFORMATION/CORRECTION: H3 - EVALUATION H6 - CODES UPDATED ATTER REVIEW OF THE INVESTIGATION, THIS CASE HAS BEEN RE-ASSESSED. THE COMPLAINT IS NOW CONSIDERED TO BE NON-REPORTABLE, NO MALFUNCTION. INVESTIGATION RESULTS: WE COULD NOT FIND ANY BLACK PARTICLES ON THE PRODUCT, DESPITE DISASSEMBLING THE FIXTURE. BATCH HISTORY REVIEW: DUE TO THE FACT, THAT NO LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE COMPLAINED DEVICE IS NOT POSSIBLE. DUE TO THE CIRCUMSTANCE THAT NO FAILURE/DEFECT COULD BE DETERMINED, THE RISK ANALYSIS IS NOT APPLICABLE. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: AS DESCRIBED IN THE ABOVE ANALYSIS, NO DEFECT WAS FOUND ON THE RECORDINGS OR OTHER BLACK PARTICLES ON THE INSTRUMENT. THE PRODUCT COMPLIES WITH THE SPECIFICATION IN ALL RESPECTS. BASED UPON THE INVESTIGATIONS RESULTS A CAPA IS NOT NECESSARY.