GOSSET ABDOMINAL RETRACTOR MED 55MM
Received Sep 10, 2020
Report 9610612-2020-00462 · MDR key 10515545
Device
Generic name
Abdominal Surgery
Manufacturer
Aesculap AgModel number
BV502RCatalog number
BV502R
Lot number
4511586012
Product problems
- Product Quality Problem
- Defective Component
- Product Quality Problem
- Defective Component
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Clinical Signs, Symptoms or Conditions
- No Known Impact Or Consequence To Patient
- 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 A ABDOMINAL RETRACTOR. ACCORDING TO THE COMPLAINT DESCRIPTION THE BLADES AND SLIDEAWAY IS NOT SEALED IN ARM. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. THE MALFUNCTION IS FILED UNDER (B)(4).
Additional Manufacturer Narrative
INVESTIGATION RESULTS: INVESTIGATION WAS CARRIED OUT VISUALLY AND MICROSCOPICALLY. ACCORDING TO THE DRAWING BV502R, THE COMPONENTS ARE WELDED AND GRINDED ON THE OUTER SIDE. THERE IS NO WELDING SEAM ON THE OPPOSITE SIDE. IT CAN BE CONFIRMED THAT THE CONNECTION POINTS ARE ACCORDING TO THE SPECIFICATION VALID AT THE TIME OF PRODUCTION. THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS (DHR) WILL BE CHECKED FOR THE LOT FROM THE QUALITY COORDINATOR OF THE PRODUCTION PLANT. IF THE REVIEW SHOWS ANY CONSPICUITIES, THE REPORT WILL BE UPDATED AND ACTIONS WILL BE INITIATED. NO DEVIATIONS CAN BE FOUND, THE DEVICE IS ACCORDING TO THE SPECIFICATION. A CAPA WAS NOT INITIATED.