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ENT MR8

MEDTRONIC POWERED SURGICAL SOLUTIONS · Model 1847B15LDF · UDI-DI 00763000356316

ERL Prescription
1
510(k) clearances
29,783
Adverse events (4 deaths)
29
Recalls
133
Facilities

Description

BUR ENTMR8 1847B15LDF DMD FINE 1.5MM LNG

Recalls

DateFirmReason
2021-12-15Medtronic Xomed, Inc.As a result of Medtronic's integrated power console (authentication number: 222ACBZX00018000) being used with software version: v2.7.3.0, it was discovered that there was a defect
2020-09-11Bien-Air Surgery SaThe magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
2020-09-11Bien-Air Surgery SaThe magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
2020-09-11Bien-Air Surgery SaThe magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
2020-09-11Bien-Air Surgery SaThe magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
2020-09-11Bien-Air Surgery SaThe magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
2020-06-12Medtronic Xomed, Inc.During internal testing execution of the next generation of Integrated Power Console (IPC) prototype it was noted that the M5 Microdebrider was rotating at a higher speed than the
2016-10-06The Anspach Effort, Inc.Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06The Anspach Effort, Inc.Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06The Anspach Effort, Inc.Supplied Directions for Use (DFU) did not contain a recommended service interval.

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Data 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.