MAUDE Adverse Event Report: CYBERSONICS INC. SHOCKPULSE LITHOTRIPSY PROBE 3.40; ELECTROHYDRAULIC LITHIOTRIPTOR

Model Number	SPL-PD340
Medical Device Problem Code	Metal Shedding Debris (1804)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to cybersonics for investigation.Scratches were observed at tip and center of the probe."use of the shockpulse-se device will always create some degree of metal debris as the metal probe vibrates ultrasonically against a metal endoscope.This is known to also occur with other ultrasonic lithotripters on the market.The amount of metal debris can be increased drastically if the user abuses the probe by bending it relative to the endoscope." proper handling instructions of probe are specified in the instructions for use (ifu).If significant additional information is received, this report will be supplemented.
Event or Problem Description
Description provided by distributor."spl-pr340 probe (lot no.W1504338) is used in a pcnl case performed by urologist.This phenomenon occurred during the 2nd time of usage.The probe was unpacked and activated with hand switch by a doctor.During procedure, a small glitter fragments; probably a coating of shockpulse probes was peel off on the patient's kidney.Doctor has removed those fragments and most of the fragments have been removed completely except for very small pieces.The result of the operation / surgery was completed safely.After the case, the subjected product has been found that the surface of probe was scratched although this case was just the second time of using".Model no.Of probes mentioned in complaint from distributor: spl-pr340 (reusable).Actual model no.Of probes shipped to distributor: spl-pdbx340 (single use, disposable probes).

• Brand Name: SHOCKPULSE LITHOTRIPSY PROBE 3.40
• Common Device Name: ELECTROHYDRAULIC LITHIOTRIPTOR
• Manufacturer (Section D): CYBERSONICS INC.; 5340 fryling road; suite 101; erie PA 16510 4703
• MDR Report Key: 6893665
• Report Number: 3004216443-2017-00001
• Device Sequence Number: 10939336
• Product Code: FEO
• UDI-Device Identifier: 00855279005122
• UDI-Public: (01)00855279005122(17)200630(10)W1504373
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K142428
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: SPL-PD340
• Device Lot Number: W1504338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2017
• Initial Report FDA Received Date: 09/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1