Richard Wolf Medical Piranha Morcellation System

This contract was awarded as a firm-fixed price but not competed due to the following:

VAMC Providence is in need of the Piranha Morcellation System comprising a laser resectoscope, morcescope, and morcellator for treatment of prostate or other morcellation procedures to remove enucleated tissue without the need to change sheaths and continuous irrigation sheaths during a procedure. Enucleation is a very niche procedure and is not performed widely due to the expertise needed but is one of the most effective.

The proprietary Piranha Morcellation System from LB OEM Richard Wolf Medical Instruments provides high flow irrigation for morcellation of a prostate to maintain bladder distension and improve surgeon visibility. It is the only purpose-made morcellator scope available in the USA and is exclusive to Richard Wolf Medical which holds an FSS contract to utilize, #36F79718D0365. There are two other Morcellation devices that were identified in the market place.

The first is the VersaCut by OEM Boston Scientific which is not in wide use and not very effective taking a lot longer to morcellate the tissue than the requested Piranha potentially leading to unnecessary delays and potential complications. The second identified is the Storz DrillCut morcellator which did produce higher efficacy in morcellation when compared with the Piranha, however it was associated with more malfunctions.

Both Morcellators have comparable rates of complications and perioperative outcomes which would adversely affect veteran care. Additionally, the Olympus scopes that have been recently leased via a VISN-wide contract would not be compatible and all new scopes would be required to be purchased which has not been budgeted for. Market Research found OEM, Richard Wolf, as the sole manufacturer and confirmed a FSS contract vehicle.

The OEM also identified SDVOSB Veterans health (ERA) as a small business partner which holds an ECAT contract; however, based on the ECAT ordering hierarchy guidance, an order off ECAT may not be made if an IDV is available. Furthermore, the FSS on GSA lists Country of Origin as the United States; however, OEM Richard Wolf confirmed these items are manufactured in both the United States and Germany.