Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
147 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Gyrus ACMI, Inc., TFL Fiber Cleaver, TFL Fiber Stripper. Olympus
Olympus does not have validated cleaning and sterilization instructions. Use of a non-sterile fiber stripper or cleaver on a ...
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Gyrus ACMI Inc, SOLTIVE Single-use Laser Fibers
A breached sterile pouch seal on the 200 Micron TFL Ball Tip Single-Use SOLTIVE Laser Fiber can lead to the potential harms of ...
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KARL STORZ SE & Co. KG-23-0015, BEYER Antrum Punch, Antrum Punch, Sphenoid Punch, Sphenoid Punch, Sphenoid Punch, Galea Spring Hook, Uvula Retractor, Optical Biopsy and Grasping Forceps, Grasping Forceps, Optical Scissor, Working Insert with steering lever
It was found that there is not insufficient evidence to show that the reprocessing method of the products was adequately ...
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Olympus Medical Systems Corporation, Single Use Distal Cover
Olympus has become aware that the Single Use Distal Cover MAJ-2315 may unexpectedly detach from the duodenoscope during use.
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Olympus Medical Systems Corporation, QIL FY24-EMEA-20-FY24-OMSC-20-GIF-1TH190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
As a result of testing, Olympus discovered EOG sterilization failures in which the GIF-1TH190 failed to achieve sterilization ...
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Gyrus ACMI, Inc. (Olympus Surgical Technologies America), QIL FY24-EMEA-32-FY24-OSTA-12, SOLTIVE Single-use Laser Fibers
Olympus conducted an internal review of the SOLTIVE Single-use Fibers and identified inconsistencies in the IFU. Olympus is ...
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Gyrus ACMI, Inc. (Olympus Surgical Technologies America), QIL FY24-EMEA-26-FY24-OSTA-07, EZDilate Fixed Wire (Guided) Balloon
Olympus is taking this recall action after investigating reported complaints about issues inflating, deflating and/or retrieving ...
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Olympus, QIL FY24-EMEA-19-FY24-OMSC-19, High Flow Insufflation Unit
Olympus has become aware of patients experiencing complications from over insufflation, including arrythmias reported as “short ...
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Olympus Medical Systems Corporation, QIL FY24-EMEA-13-FY24-OMSC-02-TJF-Q190V-290V-170V, OLYMPUS TJF-Q190V/Q290V/Q170V DUODENOSCOPE
Olympus is initiating this action after becoming aware of recent reports of infections and positive cultures. Olympus is ...
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Olympus Medical Systems Corporation, QIL FY24-EMEA-21-FY24-OMSC-26 CV-1500, EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500
Olympus has received one complaint that the water delivery tube came in contact with the touch panel and the Air flow button was ...