UTERINE CANNULAE W/2 CONES LGTH 330MM

Additional Manufacturer Narrative

ADDITIONAL INFORMATION - BLOCK A3 INVESTIGATION RESULTS: AS OF THE DATE OF THIS REPORT THE COMPLAINT PRODUCT WAS NOT PROVIDED FOR INVESTIGATION. THEREFORE, A THOROUGH INVESTIGATION IS NOT POSSIBLE. 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. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. IN THE EVENT THAT THE COMPLAINT PRODUCT WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. BASED UPON THE INVESTIGATIONS RESULTS A CAPA IS NOT NECESSARY.

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 ER876 - UTERINE CANNULAE W/2 CONES LGTH 330MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE ACORN TIP OF THE CANNULA DISCONNECTED DURING SURGERY. RETAINED FOREIGN BODY FOLLOWING PROCEDURE. PATIENT HAD AN OUTPATIENT LAPAROSCOPIC LEFT OVARIAN CYSTECTOMY. DURING PROCEDURE A COHEN UTERINE MANIPULATOR WAS USED WITH AN ACORN TOP. DURING THE PROCEDURE THE ACORN TIP BECAME DISCONNECTED FROM THE MANIPULATOR. THIS WAS NOT DETECTED DURING THE PROCEDURE. PATIENT WAS DISPOSITIONED HOME. RETURNED TO PROVIDER CLINIC THE NEXT DAY WITH COMPLAINTS OF VAGINAL FULLNESS. VAGINAL EXAM PERFORMED AND ECORN TIP DISCOVERED AND REMOVED WITH NO HARM TO PATIENT. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).