Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
152 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Unimax Medical Systems, Inc., FCA-EP24001, Detachable EndoRetrieval Pouch
The mechanism of the listed article number operates in a way that the tube within detaches during the removal process. If the ...
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Olympus Medical Systems Corporation, QIL FY24-EMEA-40-FY24-OMSC-36, Single Use Electrosurgical Knife
Olympus's investigation has identified that deterioration of the cutting knife can contribute to tip breakage during use. ...
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Intuitive Surgical, Inc., ISIFA2024-02-R, SureForm45/60, Cannula Seal, Arm Drape, Obturator
Tot onze spijt moeten wij u mededelen dat Intuitive zich ervan bewust is geworden dat bepaalde partijen van de volgende producten ...
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Covidien IIc, FA1398, Auto Suture™ Structural Balloon Trocar, Auto Suture™ Blunt Tip Trocar
We hebben meldingen ontvangen van voorvallen met betrekking tot de Covidien Auto Suture™ structurele trocar met ballon en Auto ...
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Gyrus ACMI, Inc., SG PK CUTTING FORCEPS, 5MM, 33CM. Olympus
The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure.
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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 ...