OLYMPUS WINTER & IBE GMBH GRASPING FORCEPS, OPTICAL, FOR LITHOTRIPSY, FOR 12 AND 30 TELESCOPE; ENDOSCOPE, AC-POWERED AND ACCESSORIES
|
Back to Search Results |
|
Model Number A20710A |
Device Problem
Fracture (1260)
|
Patient Problem
Foreign Body In Patient (2687)
|
Event Date 01/31/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
The device was not returned to olympus for evaluation.As no lot/serial number was provided we are unable to complete a device history record review.Customer information was not provided in mw5093593.Therefore we are unable to determine the root cause of the grasper being stuck open.This event has been reported by the importer on mdr# 2951238-2020-00430.Sus voluntary event report # mw5093593.
|
|
Event Description
|
Mw5093593 was received by the manufacturer.It was reported that during a lithotripsy, the device caused a fracture of the inner resectoscope element ceramic tip which resulted in retained foreign bodies.The grasper became stuck open and could not be removed easily through the resectoscope lumen.Removal of the grasper was able to be accomplished only after gently rotating the instrument within the resectoscope sheath.The fracture was suspected to likely be due to traction required to pull the lithotrite through the resectoscope.Some of the residual foreign body fragments were grasped and removed, but several pieces remained.Cystoscopic removal was required four days later.Radiographic confirmation of complete foreign body removal was performed at the end of the case.
|
|
Manufacturer Narrative
|
This report is being supplemented to provide additional information (h6, h10) regarding the reported event.Based on the information provided, it was determined the root cause of the reported event is a use/user error due to excessive force.It was concluded the overload safety device was triggered-the forceps remain open.As no dhr review could be completed due to no serial/lot number being provided, manufacturing and quality control review was performed for the last 24 months of production.No non-conformance or deviation regarding the described issue was found.Olympus surgical technologies of europe will continue to monitor the occurrence rate in the context of our quality management system.If necessary, we will take further action in the future.
|
|
Search Alerts/Recalls
|
|
|