Model Number GF-UCT180 |
Device Problems
Break (1069); Device Contamination with Chemical or Other Material (2944)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
The subject device was returned to (b)(4).(b)(4) checked the subject device and found the reported phenomena.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.
|
|
Event Description
|
Olympus medical systems corp.(omsc) was informed that during the incoming inspection for repair at the service department of (b)(4) it was found as follows.There was a foreign material on groove or gap of the distal end due to insufficient cleaning (handling problems).The ultrasonic transducer had deep cut that reached to the hard part under the pink probe coating due to physical stress such as dropping/knocking.There was crack on distal end cover (a gap had occurred) due to physical stress caused by handling.The occurrence date of the event is unknown.There was no report of patient injury associated with the event.
|
|
Manufacturer Narrative
|
This supplemental report is being submitted to provide additional information.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity. the exact cause of the reported event could not be conclusively determined because since no detailed information is available on the foreign material. the exact cause of the reported event could not be conclusively determined.Unable to determine the cause of the forceps cover glue peeling was attributed to whether the stress or user¿s handling, as though the way it damaged seemed similar to other damage.If additional information becomes available, this report will be supplemented.
|
|
Search Alerts/Recalls
|