KENDALL
Received Apr 12, 2017 · Event occurred Feb 27, 2017
Report 9612030-2017-05055 · MDR key 6487627
Device
Product problems
- Detachment Of Device Component
- Detachment Of Device Component
Patient
Not reported
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
SUBMIT DATE: 04/12/2017 AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
THE CUSTOMER STATES THAT THE SPONGE WAS COMING OFF THE STICK DURING A SURGICAL PROCEDURE. THE DOCTORS HAD TO RETRIEVE THE SPONGE FROM THE PATIENT'S BODY TWICE. ALTHOUGH THERE WAS PATIENT INVOLVEMENT THE CUSTOMER REPORTED THAT NO PATIENT INJURY OCCURRED.
Additional Manufacturer Narrative
THERE WERE NO SAMPLES SUBMITTED WITH THIS COMPLAINT. THE COMPLAINT SHALL BE REOPENED IF A SAMPLE IS RECEIVED. THE DEVICE HISTORY RECORD (DHR) FILE WAS REVIEWED INDICATING THAT PRODUCT WAS RELEASED MEETING ALL QUALITY STANDARD REQUIREMENTS. THERE WAS NO PHYSICAL SAMPLE RECEIVED FOR THIS REPORT THEREFORE THE ROOT CAUSE OF THE REPORTED CONDITION STATED BY THE CUSTOMER COULD NOT BE DETERMINED. AS NO PHYSICAL SAMPLES WERE RECEIVED FOR EVALUATION, THE ROOT CAUSE OF THE REPORTED CONDITION STATED BY THE CUSTOMER COULD NOT BE DETERMINED AND SUBSEQUENTLY NO FORMAL INVESTIGATION ACTIONS ARE BEING TAKEN AT THIS TIME. SHOULD A SAMPLE BE RETURNED IN THE FUTURE, THE COMPLAINT SHALL BE RE-EVALUATED AT THAT TIME. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.