Ethicon Endo Surgery Stapler
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In 2011, Johnson & Johnson’s Ethicon Endo-Surgery division issued a Class 1 recall on more than 157,000 surgical stapler devices which can malfunction, causing serious health risks, including death.
The affected products were used in hemorrhoid correction procedures and were manufactured and distributed between April 2011 and July 2012.
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Johnson & Johnson Stapler Malfunction Could Cause Death
According to the FDA, users have difficulty firing the stapler devices during surgical procedures. In some cases, the stapler was so difficult to use that the surgeon gave up on the stapler entirely during surgery. Incomplete firing strokes and incomplete staple formation may result in the following:
- Sphincter dysfunction
- Rectal wall damage
- Occlusion of the rectal canal
- Severe pain
- Bleeding and extensive blood loss
- Splitting of rectal wall staple line
Ethicon Surgical Staplers Subjected to Recall
The following Ethicon surgical staplers were recalled by Johnson & Johnson:
- Ethicon PROXIMATE HCS Hemorrhoidal Circular Stapler and Accessories 33mm (Product Code: PPH01)
- Ethicon PROXIMATE PPH Hemorrhoidal Circular Stapler and Accessories 33mm (Product Code: PPH03)
- Ethicon TRANSTAR Circular Stapler Procedure Set (Product Code: STR10)
All lots were manufactured from April 16, 2011 to July 24, 2012 and distributed from April 18, 2011 to July 23, 2012.
When Ethicon issued its original recall, Johnson & Johnson stated that the cause of the misfiring was a lubrication process change that began in April 2011. This manufacturing change could lead to problems with the device’s firing. In addition, Johnson & Johnson has discontinued the HCS stapler line entirely.