Imagine if you will the scenario of you being operated on and all of a sudden the operating table suddenly moved or tilted during the surgery. I honestly couldn’t imagine. But, apparently there have been a number of reported injuries to the FDA of this exact thing happening.
Reports that Mizuho operating tables could suddenly tilt and move patients in the middle of surgery has led to a Class 1 recall. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
A Mizuho OSI Modular Table Systems recall was announced late last month by the manufacturer, and the FDA determined that the potential threat from the tables required a Class 1 Medical Device Recall designation, which suggests that the defect is likely to cause serious injury or death.
The operating table recall came following multiple reports of patient injuries that occurred when the tables unexpectedly moved or tilted during surgery. The incorrect removal of the T-pins that support the bottom base, instead of the T-pins that support the top, may result in the lower table top and patient falling to the floor. Another potential concern is unexpected movement/tilting of the table which may result in unanticipated movement and/or patient falls during surgery. Both of the above may result in serious injury or death.
The manufacturer has suggested that the problems appear to be linked to healthcare personnel removing the wrong T-pins used to support the table. However, it could be possible that the tables are tilting or moving without the wrong pins being removed, the FDA warns.
Mizuho first warned of possible problems and provided new safe use recommendations on July 29, but the FDA is concerned that the company is too focused on possible operator error and may not have identified all of the reasons for the table malfunctions.
Although we have no specific number of how many individuals have been injured during the apparent tilting, it does not appear that any deaths have been linked to the operating tables.
The recall affects 14 models of Mizuho OSI Modular Table Systems, that were manufactured and distributed from January 1992 to June 2011 and are used for patient positioning during a variety of surgeries.
The list of recalled models, according to the FDA Medical Device Recall webpage includes:
- Advanced Control Modular Base, 120VAC 60Hz or 230VAC 50/60Hz, model number 5803/5803I
- Retractable “I” Base – Manual tilt & lock functions, model number 5890
- Non-Retractable “I” Base – Manual tilt & lock functions, model number 5891
- Advanced Control Retractable “I” Base – electric powered tilt & lock, model number 5892
- Orthopedic Trauma Table Top, model number 5855
- Maximum Access Lateral Top, model number 5895
- Radiolucent Imaging Top with Tempur-Med, model number 5927
- Imaging Top w/ Tempur-med pad (part of Model 5827 System), model number 5840-726
- Spinal Surgery Table Top (part of Jackson Spinal Surgery Top System), model number 5840-831
- Jackson Spinal Table, model number 5943
- Jackson Spinal Surgery Top w/Advanced Control Pad System 100/120VAC 50/60Hz, model number 5843AP
- Jackson Spinal Surgery Top w/Advanced Control Pad System 230VAC 50/60Hz, model number 5943API
- Advanced Control Pad System Variable Speed, model number 5996/5996I
- AXIS Jackson System with Advanced Control Pad System 100/230 VAC 50/60Hz, model number 6977
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.