(b)(4).Device evaluated by mfr: the device was returned for analysis.A visual and microscopic inspection of the device were performed.The brake button was pushed in and not sticking out of the advancer, when received.The advancer housing was opened to check the brake and it was found that the brake button was broken or damaged.Portion of the brake was not returned for analysis.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical/procedural factors.(b)(4).
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