Catalog Number 5193-06001-010 |
Device Problem
Corroded (1131)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 01/07/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
Should additional relevant information become available, a supplemental report will be submitted.
|
|
Event Description
|
It was reported that rust was observed on a pair of coupler forceps.The rust was discovered prior to patient use.There was no patient involvement.No additional information is available.
|
|
Manufacturer Narrative
|
The device was received for evaluation.A visual inspection was performed and it was noted that the forceps had brownish/orange discoloration.The reported condition was verified.The cause of the reported condition was undetermined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Search Alerts/Recalls
|