Model Number XOM UNKNOWN BLADE |
Device Problems
Break (1069); Material Fragmentation (1261)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
|
Event Type
malfunction
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
A health care provider (hcp) reported via a manufacturer representative that the blade was damaged during the procedure.There was no known patient impact reported.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Additional information received mentioned that the blade fell apart and exploded.There were no fragments left in the patient's body.There was no patient impact.
|
|
Search Alerts/Recalls
|