Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
148 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Gyrus ACMI, Inc. (Olympus Surgical Technologies America), QIL FY25-EMEA-01-FY23-OSTA-14-InstaClear Sheath, INSTACLEAR SHEATH
Olympus is taking this corrective action after investigating a complaint for an InstaClear Sheath (Model # LCS4K30BTOL) in which ...
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Ace Medical Devices PVT LTD, AFSCA.01.2023-00, Ace Bladder Evacuator
Mogelijke complicaties van blaasbreuken / perforaties / scheuren in verband met het gebruik van dit apparaat zijn aan de ...
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Intuitive Surgical, Inc., ISIFA2024-02-R, SureForm45/60, Cannula Seal, Arm Drape, Obturator
Intuitive is tot de ontdekking gekomen dat er bepaalde partijen verzonden zijn die over hun officiële vervaldatum waren.
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Olympus Medical Systems Corporation, QIL FY24-EMEA-38-FY24-OMSC-06, High Flow Insufflation Unit
Olympus has become aware of an increased trend from both repairs and customer complaints of the “UHI-4 stopping CO2 gas supply ...
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Gyrus ACMI, Inc. (Olympus Surgical Technologies America), QIL FY24-EMEA-36-FY24-OSTA-06, SOLTIVE SuperPulsed Laser System
As part of Olympus’ post market surveillance of Soltive Laser use, including a review of customer complaints and adverse events, ...
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Coloplast A/S, FSCA_20240223_Ureteral dilator, Ureteral Dilator (Ch/Fr 12-14, length 48 cm)
In de faciliteit van Coloplast is bij sommige urethraledilatorproducten een mogelijk steriliteitsprobleem ontdekt. Dit probleem ...
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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 ...