MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-26 for SHOCKPULSE LITHOTRIPSY PROBE 3.40 SPL-PD340 manufactured by Cybersonics Inc..
[87515121]
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.
Patient Sequence No: 1, Text Type: N, H10
[87515122]
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).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004216443-2017-00001 |
| MDR Report Key | 6893665 |
| Date Received | 2017-09-26 |
| Date of Report | 2017-09-20 |
| Date of Event | 2016-12-14 |
| Date Mfgr Received | 2017-05-26 |
| Device Manufacturer Date | 2015-06-30 |
| Date Added to Maude | 2017-09-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. SAMRADNI PATIL |
| Manufacturer Street | 5340 FRYLING ROAD SUITE 101 |
| Manufacturer City | ERIE PA 165104703 |
| Manufacturer Country | US |
| Manufacturer Postal | 165104703 |
| Manufacturer Phone | 8149201510 |
| Manufacturer G1 | CYBERSONICS INC. |
| Manufacturer Street | 5340 FRYLING ROAD SUITE 101 |
| Manufacturer City | ERIE PA 165104703 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 165104703 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SHOCKPULSE LITHOTRIPSY PROBE 3.40 |
| Generic Name | ELECTROHYDRAULIC LITHIOTRIPTOR |
| Product Code | FEO |
| Date Received | 2017-09-26 |
| Returned To Mfg | 2017-06-07 |
| Model Number | SPL-PD340 |
| Lot Number | W1504338 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CYBERSONICS INC. |
| Manufacturer Address | 5340 FRYLING ROAD SUITE 101 ERIE PA 165104703 US 165104703 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-26 |