450 SAL EJECTOR 3283
Received Feb 17, 2021 · Event occurred Feb 5, 2021
Report 9612030-2021-02799 · MDR key 11338638
Device
Generic name
Mouthpiece, Saliva Ejector
Manufacturer
CovidienModel number
8881450004Catalog number
8881450004
Product problems
- Detachment of Device or Device Component
Patient
Not reported
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE A LOT NUMBER WAS NOT RECEIVED WITH THE COMPLAINT. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY PRIOR TO RELEASE OF PRODUCT. A PHYSICAL SAMPLE WAS NOT RETURNED FOR EVALUATION HOWEVER, FOUR PHOTOS WERE PROVIDED FOR REFERENCE. AFTER PERFORMING A VISUAL INSPECTION AND ANALYSIS OF THE PHOTOS, THERE APPEARS TO BE A LOOSE BLUE CAP. ALTHOUGH THE REPORTED CONDITION WAS OBSERVED THROUGH THE PHOTOS, THE ISSUE COULD NOT BE DETERMINED TO BE RELATED TO THE MANUFACTURING PROCESS BY THE PHOTOS ALONE; PHYSICAL SAMPLES ARE NECESSARY FOR ANALYSIS IN ORDER TO CONFIRM QUALITY SPECIFICATIONS. IF A SAMPLE IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED. BASED ON THE ABOVE INFORMATION, AN EXACT ROOT CAUSE COULD NOT BE DETERMINED HOWEVER A POTENTIAL ROOT CAUSE FOR THE REPORTED ISSUE COULD BE DUE TO WORN OUT GRIPPERS AND SPRINGS. AT THE END OF THE ASSEMBLY PROCESS A PULL TEST IS PERFORMED ON THE TUBING AND TIP ASSEMBLY, IF THERE IS A WORN-OUT GRIPPER AND SPRINGS, IT IS POSSIBLE FOR THE MACHINE TO GRAB THE TUBE INCORRECTLY. IN ORDER TO ADDRESS THIS POTENTIAL ROOT CAUSE AND TO PREVENT ANY REOCCURRENCE, THE FOLLOWING ACTIONS WERE PERFORMED: AN ADDITIONAL PULL TEST WAS ADDED, THE GRIPPERS AND SPRINGS WERE CHANGED, THE PULL TEST WAS CALIBRATED FROM 2 TO 5 POUNDS AND A MAINTENANCE JOB PLAN WAS CREATED. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.
Additional Manufacturer Narrative
THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT.
Description of Event or Problem
THE CUSTOMER REPORTED DURING THE PROCEDURE THE BLUE TIP CAME OFF AND WAS LEFT INSIDE THE PATIENT'S ORAL CAVITY. THE HEALTH CARE PROVIDERS WERE ABLE TO REMOVE/ RETRIEVE IT. THERE WAS NO PATIENT INJURY.