REPROCESSED ARTHROSCOPIC SHAVER
Received Apr 26, 2017 · Event occurred Mar 27, 2017
Report 3032391-2017-00012 · MDR key 6521674
Device
Product problems
- Material Fragmentation
- Material Fragmentation
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE IN QUESTION WAS RETURNED TO FOR EVALUATION, AND WE CONFIRMED THAT THE DEVICE HAD BEEN REPROCESSED. WE ALSO CONFIRMED THAT THE DEVICE TIP HAD DETACHED, AND WAS RETRIEVED DURING THE PROCEDURE. A REVIEW OF THE REPROCESSING RECORDS WAS PERFORMED, AND ALL PROCESSES WERE CONDUCTED AS REQUIRED. DUE TO THE LACK OF INFORMATION SURROUNDING THE INCIDENT, MEDLINE RENEWAL DOES NOT HAVE ENOUGH INFORMATION TO DETERMINE THE SPECIFIC ROOT CAUSE OF THE FAILURE. IF MORE INFORMATION IS PROVIDED, THEN THIS REPORT WILL BE UPDATED. THERE WAS NO REPORT OF ADVERSE PATIENT CONSEQUENCE OR MEDICAL INTERVENTION AS A RESULT OF THE INCIDENT. HOWEVER, IN AN ABUNDANCE OF CAUTION, WE ARE FILING THIS MEDWATCH REPORT.
Description of Event or Problem
WE RECEIVED A REPORT INDICATING THAT THE TIP OF A REPROCESSED ARTHROSCOPIC SHAVER DETACHED AND FELL INTO THE PATIENT DURING USE. THE PHYSICIAN WAS ABLE TO LOCATE AND REMOVE THE DETACHED TIP WITHOUT PATIENT CONSEQUENCE OR ADDITIONAL MEDICAL INTERVENTION.