Block h6: imdrf device problem code a0406 captures the reportable investigation finding of side car rx push back.Block h10: the returned trapezoid rx lithotripter basket was received for analysis, and a visual inspection observed that the side car rx was pushed back, and the sheath was buckled on the proximal side.A dimensional test was performed and confirmed that the side car rx was pushed back approximately 2 mm, which is out of specification.Additionally, a functional test was performed, and the basket was able to open properly without any problems.No other issues were noted.The reported event of basket failure to open was not confirmed; however, device analysis found that the side car rx was pushed back, and the sheath was buckled, which might have affected the basket opening during the procedure.However, this cannot be confirmed since the functionality of the device during the procedure cannot be tested during analysis.The side car rx and sheath issues could be due to excessive manipulation when trying to open the stuck basket, often causing problems when too much force is applied to the handle.The technique used or the patient's anatomy might also have contributed to these problems.Therefore, the most probable root cause is adverse event related to procedure.
|