BALFOUR ABDOMINAL RETRACTOR 200X235MM

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH BV608R - BALFOUR ABDOMINAL RETRACTOR 200X235MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE BLADES ARE NOT SEALED. BLOOD ENTERS THE GAPS AND WE CAN'T GUARANTEE THE DECONTAMINATION PROCESS WILL BE SUCCESSFUL. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER AESCULAP (B)(4) REFERENCE (B)(4).

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

UPDATED: D9 NO PRODUCT RETURN. BASED UPON INVESTIGATION RESULTS, THIS EVENT WAS RE-EVALUATED AND IS CONSIDERED NO LONGER REPORTABLE - NO MALFUNCTION OR SERIOUS INJURY. INVESTIGATION RESULTS: VISUAL INVESTIGATION: PRODUCT WAS NOT PROVIDED FOR INVESTIGATION BUT PICTURES OF THE BLADES IN QUESTION. INVESTIGATION WAS CARRIED OUT BASED ON THE PICTURES PROVIDED. ACCORDING TO THE DRAWING BV608R, THE COMPONENTS ARE WELDED AND GRINDED ON THE OUTER SIDE. THERE IS NO WELDING SEAM ON THE OPPOSITE SIDE. FURTHERMORE, AFTER CONSULTATION WITH A SUBJECT MATTER EXPERT (SME) OF "LIFETIME EVALUATION & PROCESSING"-DEPARTMENT, WE RECEIVED AN EVALUATION-DOCUMENT OF A PRODUCT WITH COMPARABLE AREAS. BASED ON THIS DOCUMENT, THE CONNECTIONS IN QUESTION CAN BE CLEANED AND DISINFECTED EFFICIENTLY. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS WILL BE CHECKED FOR THE LEADING DEVICE(S) LOT NUMBER FROM THE QUALITY COORDINATOR OF THE PRODUCTION PLANT. THE RESULTS OF THE REVIEW WILL BE DOCUMENTED IN THE NOTIFICATION. IF REVIEW SHOWS ANY CONSPICUITIES, THE REPORT WILL BE UPDATED AND ACTIONS WILL BE INITIATED. REVIEW OF THE COMPLAINT HISTORY REVEALED THAT THERE ARE NO SIMILAR COMPLAINTS FILED AGAINST PRODUCTS FROM THIS BATCH NUMBER. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION OF THE PICTURES PROVIDED, PRODUCT WAS ACCORDING TO SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. BASED UPON THE INVESTIGATIONS RESULTS A CAPA IS NOT NECESSARY.