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n.a.
Karl Storz GmbH & Co. KG · Model 12062B · UDI-DI 04048551053201
EOX
Prescription
10
510(k) clearances
25
Adverse events
8
Recalls
37
Facilities
Description
Insertable Suction Tube
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-04-24 | Lucid Diagnostics, Inc. | The EsophaCap sponge may be at increased risk of detaching from the string during removal of the device from the patient, particularly at the lower esophageal sphincter at the gast |
| 2024-04-24 | Lucid Diagnostics, Inc. | The EsophaCap sponge may be at increased risk of detaching from the string during removal of the device from the patient, particularly at the lower esophageal sphincter at the gast |
| 2023-06-02 | Covidien, LLC | Cell Collection Device may be at increased risk of the sponge detaching from the string during removal of the device from the patient, which could lead to device fragments in patie |
| 2021-08-16 | Olympus Corporation of the Americas | The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Label |
| 2016-06-06 | Covidien, LLC | Medtronic is recalling all lots of the Covidien Cytosponge Cell Collection device after two reports of the device detaching from the removal string during withdrawal from the patie |
| 2016-06-06 | Covidien, LLC | Medtronic is recalling all lots of the Covidien Cytosponge Cell Collection device after two reports of the device detaching from the removal string during withdrawal from the patie |
| 2011-09-30 | Pentax Medical Company | The wrong silicone sealant was used and excess sealant was neglected to be removed during repair of the bronchoscope. |
| 2011-09-30 | Pentax Medical Company | The wrong silicone sealant was used and excess sealant was neglected to be removed during repair of the bronchoscope. |
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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.