Endoscope, Ac-powered And Accessories

Olympus Cystoscope Outer Sheath;

Product being removed due to incompatibility when used in conjunction with a GreenLight Laser for BPH therapy which could damage the tip of the device.

Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Brand Name: Olympus

Olympus is removing the statement of compatibility with a GreenLight Laser for BPH therapy from the Instruction for Use (IFU) due to the potential for a damaged tip during use of a laser probe.

A20975A "Working insert, with ramp, one way" (Lots 13ZW to 172W; A20976A "Bridge, one way" (Lots 146W to 172W) and A20977A "Bridge, two way" (Lots 146W to 174W)

Olympus has received complaints about fragments of adhesive which detached from inside the working channel of the referenced products. Cracking, chipping, missing pieces, and delamination of the adhesive have also been reported. In one case, a fragment of the adhesive was detected inside a patient's urethra during a procedure and was retrieved without injury to the patient. The manufacturer, Olympus Winter & lbe GmbH ("OWi") has determined that adhesive can be dislodged during the intended use of the cystoscopy bridge or working insert, e.g., when inserting an instrument through the working channel. As a result, a fragment of the adhesive may fall inside the patient's bladder, urethra or uterus and would need to be retrieved, extending the length of the procedure or requiring additional surgical treatment. The adhesive is used to seal gaps inside the working channel of the cystoscopy bridges and working inserts. In 2013, the adhesive used until then was discontinued and had to be replaced. Current investigations revealed that the durability of the new adhesive is insufficient

High Frequency Resection Electrodes, endoscope, ac-powered and accessories

Loop wires breaking at the distal end of the Monopolar HF Resection Electrodes.