Endoplus
Endoplus · Model E321AC-32 · UDI-DI 00817401028362
HET
Prescription
1
510(k) clearances
16,889
Adverse events (24 deaths)
19
Recalls
151
Facilities
Description
5mm Claw Forcep 2x3 Teeth, Auto Closure Handle, Custom Length 32cm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-02-27 | Karl Storz Endoscopy | Inadequate reprocessing validation evidence |
| 2023-11-20 | Olympus Corporation of the Americas | Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for the proper reprocess |
| 2023-11-20 | Olympus Corporation of the Americas | Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for the proper reprocess |
| 2023-11-06 | Olympus Corporation of the Americas | Reports of a pink or green coloration of the image. If the issue is encountered during a procedure, device exchange could potentially result in prolonged surgery; potential visual |
| 2023-10-24 | Karl Storz Endoscopy | The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the pa |
| 2022-02-23 | Carefusion 2200 Inc | The finished device package did not contain the IFU. |
| 2017-02-10 | Olympus Corporation of the Americas | A damaged temperature sensor at the endoscope's tip can cause the endoscope's distal end to become abnormally hot. |
| 2015-11-17 | Olympus Corporation of the Americas | A damaged temperature sensor at the ENDOEYE tip caused the distal end to become abnormally hot. Excessive heating of the ENDOEYE distal end could result in patient or user injury. |
| 2014-07-16 | Market-Tiers Inc | Some pages of the Instructions for Use were omitted, including pages regarding the Indications for Use, Warning, and Contraindications. |
| 2009-09-28 | Ethicon, Inc. | There is the potential for the duckbill seal to become dislodged. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.