|
Model Number 59004 |
Device Problem
Break (1069)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Hillrom is reporting this event in an abundance of caution.The disposable vaginal speculum is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures.The vaginal speculum can be used with or without the illuminator.The actual vaginal speculum was not returned to hillrom.This device is a manually inserted, disposable vaginal speculum.It is unknown what caused the breakage at the bill of the device as the device could not be inspected.The customer has requested a replacement.Hillrom will continue to monitor any similar reported events.Based on this information, no further action is required and no further investigation will be performed.
|
|
Event Description
|
The customer reported while performing a pap test on a patient, vaginal speculum disposable premium 590 series large broke off inside of our patients vaginal cavity.The customer additionally clarified that during the exam, the bill of the spec broke off in the patient.The patient did not sustain any injury.The patient passed the broken piece overnight.The patient was prescribed a prophylactic antibiotic but reported it was not needed or taken as the customer reported that she passed the piece was passed and that she was fine.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).
|
|
Search Alerts/Recalls
|
|
|