This is the first article in which concerns regarding the significant morbidity and mortality following procedures using this device are discussed. The failures are clearly delineated and certainly do raise alarm for the types and magnitude of the complications. While any mechanical device utilized for hemostasis of the renal hilum during nephrectomy can be associated with mechanical failure resulting in inadequate hemostasis, it is the delayed nature of the presentation of these complications with the Hem-o-lok clip that is of concern. Between 1996 and 2005, 27 adverse events have been reported to the FDA involving the Hem-o-lok clip, and 44% of these were involved with the removal of a kidney. Of 13 adverse events during laparoscopic nephrectomy, 8 (62%) were during live donor nephrectomy. Of these 8 cases, 2 (25%) resulted in death due to delayed postoperative bleeding from the renal artery. On review of all of the adverse events related to the Hem-o-lok clip, none were noted during the operation, and the clips apparently had been placed without issue, but subsequently did not maintain control of the vessel. As the author notes, in most problems with linear staplers (Endo-GIA and Endo-TA) nearly all are noted during the application, firing, or removal of the device, and bleeding occurs immediately. This provides the opportunity to correct the situation immediately; albeit, most occurrences require conversion to open surgery. This article, highlights the apparent need for more research of the mechanism of the Hem-o-lok clip and its appropriate use with regards to size of vessel, amount of tissue, and type of tissue encompassed by the clip material. Until these characteristics can be adequately addressed, this device should be avoided particularly during live donor laparoscopic nephrectomy.

Meng, MV

J of Endour; 20 (12); 1054-1057

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Written by Elspeth M. McDougall, MD, a Contributing Editor with UroToday.

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