UTERINE CANNULAE W/2 CONES LGTH 330MM
Received Mar 18, 2021 · Event occurred Jan 22, 2021
Report 2916714-2021-00039 · MDR key 11516144
Device
Product problems
- Disconnection
- Separation Problem
- Disconnection
- Separation Problem
Patient
Not reported
- Foreign Body In Patient
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Foreign Body In Patient
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Additional Manufacturer Narrative
INVESTIGATION RESULTS: MANUFACTURING SITE EVALUATION: THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONALLY, NO ON-SITE EVALUATION OF THE UNIT WAS PERFORMED AND NO PARTS WERE RETURNED FOR FAILURE ANALYSIS. THEREFORE, THE INVESTIGATION WAS NOT ABLE TO CONFIRM A DEVICE ISSUE THAT COULD BE ASSOCIATED WITH THE REPORTED EVENT. THE DEVICE HISTORY RECORDS (DHR) WERE NOT ABLE TO BE REVIEWED AS THE LOT NUMBER WAS NOT MADE AVAILABLE. HOWEVER, ALL DEVICE HISTORY RECORDS (DHR) ARE REVIEWED AND RELEASED ACCORDING TO DOCUMENTED PROCEDURES AND A DEVICE IS NOT RELEASED IF IT DOES NOT MEET REQUIREMENTS OR IS NONCONFORMING. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE.
Description of Event or Problem
NO CHANGE.
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 REPORT MW5099049, DETACHMENT OF DEVICE COMPONENET DURING PROCEDURE. UNDETECTED. 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. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).