COVIDIEN
Received Mar 29, 2019 · Event occurred Mar 11, 2019
Report 3032391-2019-00004 · MDR key 8465123
Device
Product problems
- Mechanical Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT DURING AN UNSPECIFIED PARATHYROID PROCEDURE, TWO REPROCESSED COVIDIEN LIGASURE¿ SMALL JAW INSTRUMENTS WOULD NOT SEAL PROPERLY. REPORTEDLY, THIS EXTENDED THE PROCEDURE FOR 45 MINUTES REQUIRING ADDITIONAL ANESTHESIA FOR THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY FINISHED AND THERE WAS NO EFFECT ON THE PATIENT'S STATUS/STABILITY AS A RESULT OF THIS INCIDENT. DUE TO THE REPORTED EXTENSION OF THE PROCEDURE TIME AND NEED FOR ADDITIONAL ANESTHESIA, THIS MEDWATCH IS BEING FILED. THE DEVICES WERE RETURNED FOR EVALUATION. THE MEDLINE RENEWAL PACKAGING, WHERE LOT INFORMATION IS PRINTED, WERE NOT RETURNED. UPON VISUAL AND FUNCTIONAL INSPECTION OF THE RETURNED DEVICES, THE REPORTED ISSUE WAS CONFIRMED AND A CORRECTIVE ACTION WAS INITIATED. THE ROOT CAUSE WAS CORROSION OF THE CERAMIC ISOLATION DOTS, FOUND ON THE SEALING PART OF THE DEVICES. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT TWO REPROCESSED COVIDIEN LIGASURE¿ SMALL JAW INSTRUMENT WOULD NOT SEAL PROPERLY DURING A PARATHYROID PROCEDURE RESULTING IN PATIENT REQUIRING ADDITIONAL ANESTHESIA DUE TO A 45-MINUTE EXTENSION OF THE PROCEDURE.