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Woman's Bowel Stapled Shut: Doctor Wielding Defective Staple Gun

Tuesday, August 13, 2013By Richard Alexander

By Richard Alexander

Proximate PPH Procedure Set PPHO3Retired San Jose Police Officer Florence Kuhlmann, 59, had her bowel stapled shut by a surgeon using a defective staple gun during hemorrhoid surgery, according to the allegations of a lawsuit filed by the Alexander Law Group. The complaint alleges defendants Johnson & Johnson, the Pleasanton Surgery Center, LLC and Rakhee N. Shah, M.D. of Pleasanton as the parties responsible for the devastating injuries that occurred on January 27, 2012 at the Pleasanton Surgery Center.

The complaint alleges the staple gun was manufactured by Ethicon Endo-Surgery, LLC, a subsidiary of Johnson & Johnson.

Dr. Shah reported that the staple gun misfired and had to be re-locked and re-fired during the surgery. In the hands of Dr. Shah this staple gun caused lifetime injuries to Florence Kuhlmann.

The staple gun, a single use surgical device, labeled a Proximate PPH Procedure Set PPHO3 by Ethicon Endo, was recalled on August 3, 2012, six months after Florence Kuhlmann’s surgery.

The complaint alleges the manufacturer knew the dangers of the product, including” “misfiring, incomplete firing strokes, and incomplete staple formation and the resulting consequences for many patients included sphincter dysfunction, rectal wall damage, sepsis, and bleeding.”

Florence has suffered unbelievably, starting with 21 days of emergency hospitalization, massive infection and major abdominal surgeries that resulted in a full laparotomy -- surgical opening of her complete abdomen -- and a colostomy. She is plagued by external and internal scarring, continues to struggle with a deformed bowel, has been forced to wear a colostomy bag and has had multiple medical procedures attempting to restore her damaged bowel.

A search of the FDA Manufacturer and User Device Experience internet database lists more than 750 adverse events, two deaths and over 150 serious injuries involving this product. Between March, 2007 and June, 2012 there were nearly 100 cases involving injuries related to the firing of staple gun during an operation. This is the tip of the iceberg.

This staple gun should have been recalled long before Florence Kuhlmann’s life was changed forever.

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