Catalog Number 0306330000 |
Device Problem
Fracture (1260)
|
Patient Problems
Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/30/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 4 events were reported for this quarter.Product return status: 1 device was received.3 device investigation types have not yet been determined.Additional information: 4 devices were labeled for single-use.4 devices were not reprocessed or reused.
|
|
Event Description
|
This report summarizes 4 malfunction events in which the device or cutting accessory fractured.4 events had patient involvement; no patient impact.
|
|
Manufacturer Narrative
|
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: 4 previously reported events are included in this follow-up record.Product return status: 2 devices were received.2 devices were not available for evaluation.
|
|
Event Description
|
This report summarizes 4 malfunction events in which the device or cutting accessory fractured.4 events had patient involvement; no patient impact.
|
|
Search Alerts/Recalls
|