Model Number 7305001 |
Device Problem
Insufficient Information (3190)
|
Patient Problem
Low Oxygen Saturation (2477)
|
Event Date 02/16/2024 |
Event Type
Injury
|
Event Description
|
A medical supplier and richard wolf gmbh (rwgmbh) has been informed of an issue regarding an fiber-cystoscope 15fr wl 400mm, part id: 7305.001, sn# (b)(6).According to the received information, the general hospital of nikaia in athens reported three serious incidents with patients developing a severe hypoxemia, 10-15 minutes following cystoscopy.One of the patient had to be transferred to the intensive care unit.These happened on (b)(6) jan, (b)(6) feb, and (b)(6) 2024 respectively.The cases were started after the use of the instrument.All patients are now doing well.
|
|
Manufacturer Narrative
|
The medical supplier sold the fiber-cystoscope 15fr wl 400mm, 7305.001, to the general hospital of nikaia in athens in january 2024 and was used for 25 cases after the reported incident happened.Rwgmbh has been provided information via the incident questionnaire that the defect did not occurred during the use of the device.Added, no risk to patient, users or third parties.Also, information regarding reprocessing, that listed two chemicals that have not been tested and/or approved by rwgmbh.Rwgmbh has requested the return of the product for further investigation.
|
|
Search Alerts/Recalls
|
|