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Olympus Corporation of the Americas Recall 88448

Description: Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general open surgical procedures when used in conjunction with the Gyrus ACMI G400 workstation Ref: 970010PC

Olympus Corporation of the Americas Recall 88448 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2380-2021
Event ID88448
Event DescriptionGyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general open surgical procedures when used in conjunction with the Gyrus ACMI G400 workstation Ref: 970010PC
Product TypeDevices
DistributionUS Nationwide distribution in the states of CA, GA, MN, TN.
Quantity6 boxes (5 per/box)=30 units
Recall ReasonExpired adhesive used as an electrical insulation barrier and as a secondary retention bond failed and could result in foreign body / biologic reaction within the patient and / or electrical continuity to patient causing tissue burn to critical structures.
Device Classification20210908
Device Code InfoLot number KR121617
Center Classification Date20210827
Recall Initiation Date20210609
Recalling FirmOlympus Corporation of the Americas
Initial Notification Letter
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