It was reported this retrieval was used to successfully engage a stone from the pt's ureter.
A laser fiber was then advanced to break up the stone.
Upon removal of the basket resistance was encountered.
The device was removed and it was noted at that time, the distal portion of the retrieval basket remained in the pt.
Surgical retrieval of the basked was successful.
The pt's condition is good.
The device was received and evaluated by this mfr.
A portion of the basked remained attached to the device and a small section of a basket was returned in a specimen container.
The section of basket attached to the device had all four pairs of wire broken in a staggered manner.
None of the pairs were broken in the same location.
The distal section of the basket received in the specimen cup was broken in the same manner.
The broken edges of two sets of paired wires were blackened, indicating possible contact with a laser fiber.
One set of wires was bent severely, as if it had been forced back and forth in an attempt to break the wire, and the remaining set appears to have been cut.
Although the medwatch report received from the user facility indicated a laparotomy was performed, co's f/u revealed the procedure was a cystoscope stone retrieval/laser lithotripsy.
Further info as well as the engineering evaluation indicated the basket wires appears to have been melted from the laser fiber.
Co believes direct fire of the laser on the basket wires may have contributed to this and do not attribute it to the device.
The directions for use state: "the helical basket is designed to be used through the small working channel of an endoscope, such as a ureteroscope or nephroscope during the procedure.
This device must not come in contact with any electrified instrument.
This device should not be directly fired upon by a pulsed dye laser.
If resistance is encountered while attempting to withdraw the basket into the sheath or the sheath through the scope, do not exert excessive force.
A1, a2, a3, a4, b6, b7, d10 - unk/no info available from user facility.
Date mfr forwarded report to fda.
Info supplied in section f was completed by the mfr based on info obtained from the user facility.
Any info not included in this section was na at the time of submission of this medwatch report to the fda.