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DeRoyal
DEROYAL INDUSTRIES, INC. · Model 25-3002 · UDI-DI 00749756025720
GAG
Prescription
10
510(k) clearances
26,629
Adverse events (276 deaths)
10
Recalls
80
Facilities
Description
SKIN STAPLER
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-05-13 | Covidien, LP | The affected staplers have the potential for the staple guide to not be securely attached to the instrument. The issue could cause the component to disengage and if disengaged, cou |
| 2019-07-01 | Intuitive Surgical, Inc. | The firm became aware of a manufacturing variation in which black and green reloads in select Stapler Reloads may not deploy individual adjacent staples, which could result in an i |
| 2019-07-01 | Intuitive Surgical, Inc. | The firm became aware of a manufacturing variation in which black and green reloads in select Stapler Reloads may not deploy individual adjacent staples, which could result in an i |
| 2018-08-17 | COVIDIEN LLC | The firm identified the potential for a device to have an incorrect tissue gap. Use of a device with an incorrect tissue gap may result in incomplete staple formation and/or the in |
| 2014-08-12 | Ethicon Endo-Surgery Inc | The device may have a non-conforming component that may cause the device to fire an unformed staple. |
| 2013-05-03 | Surgical Instrument Service And Savings, Inc. | The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. |
| 2012-10-04 | Ethicon Endo-Surgery Inc | Damage to the packaging may have compromised the sterility of the device. |
| 2010-04-01 | Cardinal Health | The sterility of the staplers is questionable. |
| 2003-06-30 | Power Medical Interventions | latching mechanism failure |
| 2003-06-30 | Power Medical Interventions | latching mechanism failure |
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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.