|
Model Number GWH3805R |
Device Problem
Material Frayed (1262)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/01/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
|
|
Event Description
|
The customer reported during a therapeutic foley catheter placement, the subject device frayed on removal within the catheter tubing.The patient was being catheterized post-operatively in the pacu because they were not spontaneously voiding.Urology was contacted to insert the catheter to avoid urethral trauma.While advancing an 18 french coude foley catheter into the urethra, resistance was met at the expected position of the bulbar urethra and the catheter was removed.Next the subject device was advanced into the bladder and a 5 french pollack catheter was used to confirm positioning in the bladder.Then a 6 french council tip catheter was attempted to be advanced over the wire however similar resistance was encountered at the level of the bulbar urethra and the catheter was removed.Next a 14 french silicone catheter was used as a council tip catheter by puncturing the tip with the angiocatheter; this was then advanced over the wire into the bladder with a return of more than one (1) liter of clear yellow urine.Upon removal of the subject device, the wire frayed within the catheter tubing.Since the wire could not be removed in it's entirety, the catheter and the wire were removed together atraumatically.A kub confirmed removal of the wire.The customer reported it is unknown if the subject device was inspected prior to use.
|
|
Manufacturer Narrative
|
This supplement is being submitted to update the reportability status of the event per the legal manufacturer.The new information was added to b1.
|
|
Manufacturer Narrative
|
This supplemental report is being submitted to provide the results of the device evaluation, legal manufacturer¿s investigation and the results of the device history records (dhr) review.The dhr for this device were reviewed and all records indicated the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The olympus service center evaluated the device and found the following: the device was visual inspected and it was confirmed to have many areas frayed and different components unraveling/loose.In addition, the wires had many unnatural bends and dents.Along with the wires, the end of the clear plastic tubing appears to have a tear as if it was caught on something sharp.A definitive root cause was not identified.Based on the available information, the legal manufacturer determined the probable cause of the failure is likely due to the wire jammed during application and was pulled with high force, which exceeded the specified load limit and thus led to the breakage of the connection between the spring and the core wire.This then caused the spring to unravel.
|
|
Search Alerts/Recalls
|
|
|