Pentax medical was made aware of a complaint on 24-jun-2021 that occurred in the united states.The reported complaint of "no video image" involving pentax medical video processor, model epk-i5010, serial number (b)(4).The user facility responded to good faith efforts(gfe) via email on 28-jun-2021 and stated that the no video image occurred during the pre-inspection check and that the endoscope was removed from circulation immediately after the failure/event occurred and subsequently called in for service/replacement and that they follow the ifus for reprocessing and accessories.No additional information was provided.The customer owned processor was received by pentax medical for evaluation on 30-jun-2021.The endoscope was inspected by pentax medical service under service order (b)(4) and the technician documented the following inspection findings on 02-jul-2021: process pcb digital video failure, limit switch actuator plate(2) bent, scope connector handle loose, control panel unit button not functioning.The device underwent repairs including the following components:cable to limit sw, pcb for process ntsc (rohs complied).This is the first time pentax model epk-i5010, serial number (b)(4) has been returned for serviced at a pentax facility since the device was put into service on 17-sep-2015.The endoscope wasrepair and approval by final qc on 21-jul-2021 and delivered to the customer under delivery order (b)(4).
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