Reports of patient injuries and related incidents have led to a Class I recall and health professional advisory of the Mizuho OSI Modular Table Systems, the U.S. Food and Drug Administration (FDA) just announced. A Class I recall, the agencyâ€™s most severe, involves a situation in which there is a reasonable probability that use of the recalled product will cause serious adverse health consequences or death.
Incorrect removal of the T-pins that support the bottom base, instead of the T-pins that support the top, may result in patients falling to the floor. Also, unexpected movement or tilting of the table could result in unanticipated movement and/or patient falls during surgery. The potential for patient falls or unanticipated movement may result in serious injury or death.
The recalled Mizuho OSI Modular Table Systems are used for patient positioning during an array of orthopedic trauma, thoracic, and spinal surgery procedures and include Modular Bases and Jackson Spinal, Imaging, Lateral, and Orthopedic Tops, which were manufactured from January 1992 through June 2011 and distributed from January 1992 through June 2011. The following models/product names are involved:
â€¢ Advanced Control Modular Base 120VAC 60Hz or 230VAC 50/60Hz/model 5803/5803I.
â€¢ Retractable â€œIâ€ Base with manual tilt and lock functions/model 5890.
â€¢ Non-Retractable â€œIâ€ Base with manual tilt and lock functions/model 5891.
â€¢ Advanced Control Retractable â€œIâ€ Baseâ€”electric-powered tilt and lock/model 5892.
â€¢ Orthopedic Trauma Table Top/model 5855.
â€¢ Maximum Access Lateral Top/model 5895.
â€¢ Radiolucent Imaging Top with Tempur-Med/model 5927.
â€¢ Imaging Top with Tempur-Med Pad (part of the Model 5827 system)/model 5840-726.
â€¢ Spinal Surgery Table Top (part of Jackson Spinal Surgery Top system)/model 5840-831.
â€¢ Jackson Spinal Table/model 5943.
â€¢ Jackson Spinal Surgery Top with the Advanced Control Pad System 100/120VAC50/60Hz/model
â€¢ Jackson Spinal Surgery Top with the Advanced Control Pad System 230VAC50/60Hz/model 5943API.
â€¢ Advanced Control Pad System Variable Speed/model 5996/5996I.
â€¢ AXIS Jackson System with the Advanced Control Pad system 100/230VAC50/60Hz/model 6977.
On July 29, 2011, Mizuho issued a Field Advisory Notice to Hospital Risk Management, Operating Room Directors, Operating Room Technicians, Physicians, Nurses, Anesthesiologists, and any personnel involved in the use and/or set up of the OSI Modular Table systems. The Notice provided warnings and recommendations for the safe use of the Mizuho OSI Modular Table systems, including performing a verification count of all of the T-pins to confirm the table topâ€™s stability.
The FDA stated that while it agrees that the factors identified by Mizuho may have contributed to some reported failures, the agency is concerned that Mizuho has not identified all factors contributing to these events. Mizuhoâ€™s toll-free hot-line is 1.800.777.4674, and can be reached Monday through Friday from 9:00 a.m. to 5:00 p.m., Pacific Time (PT). The FDA also stated that health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail, or by FAX here.