MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-27 for LITHOTRIPSY PROBE, STERILE SINGLE USE SHOCKPULSE-SE SPL-PD340 manufactured by Cybersonics Inc.
[87520695]
Patient Sequence No: 1, Text Type: N, H10
[87520696]
Patient came to operating room for cystoscopy with lithotripsy. Surgeon was using shock pulse machine with shock pulse probe. Shock pulse probe broke in half. A new probe was opened and used to complete procedure. Manufacturer response for lithotripsy probe, olympus lithotripsy probe (per site reporter): manufacturer provided rga# for product return evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6897755 |
| MDR Report Key | 6897755 |
| Date Received | 2017-09-27 |
| Date of Report | 2017-09-25 |
| Date of Event | 2017-09-08 |
| Report Date | 2017-09-25 |
| Date Reported to FDA | 2017-09-25 |
| Date Reported to Mfgr | 2017-09-25 |
| Date Added to Maude | 2017-09-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LITHOTRIPSY PROBE, STERILE SINGLE USE SHOCKPULSE-SE |
| Generic Name | LITHOTRIPTOR, ULTRASONIC |
| Product Code | FEO |
| Date Received | 2017-09-27 |
| Returned To Mfg | 2017-09-25 |
| Model Number | SPL-PD340 |
| Catalog Number | SPL-PD340 |
| Lot Number | W1700704 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CYBERSONICS INC |
| Manufacturer Address | KNOWLEDGE PARK, 5340 FRYLING ROAD SUITE 101 ERIE PA 16510 US 16510 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-27 |