TAUT INTRADUCERS 10/BX7.5 FR X 3.5
Received Mar 20, 2017 · Event occurred Feb 8, 2017
Report 3003898360-2017-00170 · MDR key 6417034
Device
Product problems
- Material Separation
- Material Separation
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). THE FACILITY HAS COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.
Description of Event or Problem
THE INNER LINING OF A TAUT INTRODUCER CAME APART AFTER A CHOLANGIOGRAM WAS COMPLETED. THE SURGEON REMOVED PIECES OF THE TAUT INTRODUCER. THE REMAINDER OF THE CHOLECYSTECTOMY WAS COMPLETED WITHOUT ANY FURTHER PROBLEMS. PATIENT WENT TO RECOVERY IN STABLE CONDITION. NO UNTOWARD PATIENT EFFECT.
Additional Manufacturer Narrative
(B)(4). PER DHR THE PRODUCT TAUT INTRODUCERS 10/BX7.5 FR X 3.5, LOT # 73J1600710 WAS MANUFACTURED ON 10/03/2016 A TOTAL OF (B)(4) PIECES. LOT WAS RELEASED ON 10/06/2016. DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. CORRECTIVE ACTIONS CANNOT BE ESTABLISHED SINCE IT IS NECESSARY TO RECEIVE THE PHYSICAL SAMPLE TO PERFORM A PROPER INVESTIGATION AND CONFIRM THE ALLEGED DEFECT. AT THIS TIME DUE THE SAMPLE IS NOT AVAILABLE IS NOT POSSIBLE TO DETERMINE THE SOURCE OF THE DEFECT REPORTED. CUSTOMER COMPLAINT CANNOT BE CONFIRMED DUE THE PRODUCT SAMPLE IS NOT AVAILABLE TO PERFORM A PROPER INVESTIGATION AND DETERMINATE THE ROOT CAUSE. IF THE ALLEGED DEFECT SAMPLES BECOME AVAILABLE AT A LATER DATE, THIS COMPLAINT WILL BE UPDATED ACCORDINGLY.
Description of Event or Problem
THE INNER LINING OF A TAUT INTRODUCER CAME APART AFTER A CHOLANGIOGRAM WAS COMPLETED. THE SURGEON REMOVED PIECES OF THE TAUT INTRODUCER. THE REMAINDER OF THE CHOLECYSTECTOMY WAS COMPLETED WITHOUT ANY FURTHER PROBLEMS. PATIENT WENT TO RECOVERY IN STABLE CONDITION. NO UNTOWARD PATIENT EFFECT.