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DeRoyal
DEROYAL INDUSTRIES, INC. · Model 88-000M13C · UDI-DI 00749756136013
10
510(k) clearances
777
Adverse events
24
Recalls
63
Facilities
Description
Coated Blade Electrode
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0 |
| 2021-09-29 | CooperSurgical, Inc. | XXX |
| 2021-09-29 | CooperSurgical, Inc. | Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to co |
| 2021-09-29 | CooperSurgical, Inc. | Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to co |
| 2021-09-29 | CooperSurgical, Inc. | Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to co |
| 2021-09-29 | CooperSurgical, Inc. | Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to co |
| 2021-09-29 | CooperSurgical, Inc. | Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to co |
| 2021-09-29 | CooperSurgical, Inc. | Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to co |
| 2019-10-16 | CooperSurgical, Inc. | Potential for the Quantum 2000 Electrosurgery Generator, part numbers 909075, 909075-05 and 909075-05W, to cease to either cut, coagulate, or blend during a procedure when the foot |
| 2019-10-16 | CooperSurgical, Inc. | Potential for the Quantum 2000 Electrosurgery Generator, part numbers 909075, 909075-05 and 909075-05W, to cease to either cut, coagulate, or blend during a procedure when the foot |
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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.