Olympus Corporation of the Americas: HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological or gynecological applicati

Hazard

Additional Caution statements in IFU: (1) Due to complaints where the loop wire at the distal end of the HF resection electrode broke after getting in contact with metal objects, such as other endoscopic equipment, implants or stents. As a result, fragments can fall inside the patient and must be retrieved. (2) The second Caution refers to the risk of sparkover when getting in contact with metal parts as this can cause uncontrolled heating of the HF-resection electrode and may result in damage and breakage to the HF-resection electrode tip

Details from the source

Reason for recall: Additional Caution statements in IFU: (1) Due to complaints where the loop wire at the distal end of the HF resection electrode broke after getting in contact with metal objects, such as other endoscopic equipment, implants or stents. As a result, fragments can fall inside the patient and must be retrieved. (2) The second Caution refers to the risk of sparkover when getting in contact with metal parts as this can cause uncontrolled heating of the HF-resection electrode and may result in damage and breakage to the HF-resection electrode tip Distribution: US Nationwide distribution. Quantity: 62704 boxes Lot/code info: # Model UDI(DI) 1) A22201C 14042761036648 2) A22201D 14042761036655 3) A22202C 14042761036662 4) A22203C 14042761036686 5) A22205C 14042761036709 6) A22205D 14042761036716 7) A22206C 14042761036723 8) A22207C 14042761036747 9) A22211C 14042761036761 10) A22221C 14042761029466 11) A22222C 14042761030431 12) A22223C 14042761029770 13) A22231C 14042761036778 14) A22231D 14042761036785 15) A22251C 14042761036815 16) A22253C 14042761036822 17) A22255C 14042761036839 18) A22257C 14042761030448 19) A22258C 14042761036853 20) A22266C 14042761036891 21) A44728C 14042761039090 22) WA22037C 14042761051566 23) WA22038C 14042761051580 24) WA22039C 14042761051603 25) WA22301D 14042761051658 26) WA22301S 14042761082386 27) WA22302D 14042761051665 28) WA22305D 14042761051672 29) WA22305S 14042761082393 30) WA22306D 14042761051689 31) WA22332D 14042761051702 32) WA22351C 14042761051719 33) WA22355C 14042761051719 34) WA22503D 14042761068205 35) WA22507D 14042761068236 36) WA22521C 14042761068243 37) WA22523C 14042761068267 38) WA22537D 14042761073940 39) WA22538C 14042761073964 40) WA22539D 14042761073971 41) WA22540S 14042761083710 42) WA22541S 14042761083727 43) WA22542S 14042761083734 44) WA22544S 14042761083758 45) WA22557C 14042761068342 46) WA22566S 14042761083765 47) WA22602D 14042761075456 48) WA22603D 14042761075463 49) WA22606D 14042761075470 50) WA22607D 14042761075487 51) WA22621C 14042761075494 52) WA22623C 14042761075500 53) WA22632D 14042761075517 54) WA22651C 14042761075524 55

UPC codes

14042761036648, 14042761036655, 14042761036662, 14042761036686, 14042761036709, 14042761036716, 14042761036723, 14042761036747, 14042761036761, 14042761029466, 14042761030431, 14042761029770, 14042761036778, 14042761036785, 14042761036815, 14042761036822, 14042761036839, 14042761030448, 14042761036853, 14042761036891, 14042761039090, 14042761051566, 14042761051580, 14042761051603, 14042761051658, 14042761082386, 14042761051665, 14042761051672, 14042761082393, 14042761051689, 14042761051702, 14042761051719, 14042761068205, 14042761068236, 14042761068243, 14042761068267, 14042761073940, 14042761073964, 14042761073971, 14042761083710

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.