Model Number 5100015250 |
Device Problem
Material Disintegration (1177)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/31/2023 |
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 not labeled for single-use; 4 devices were not reprocessed or reused.
|
|
Event Description
|
This report summarizes 4 malfunction events in which the device was shedding metal debris.- 1 event had no patient involvement; no patient impact.- 3 events had patient involvement; no patient impact.
|
|
Event Description
|
This report summarizes 4 malfunction events in which the device was shedding metal debris.1 event had no patient involvement; no patient impact.3 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: 1 device was received.3 devices were not available for evaluation.
|
|
Search Alerts/Recalls
|