MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-01 for OLYMPUS SHOCKPULSE SE SPL-PD376 manufactured by Olympus Surgical.
[48631727]
Patient Sequence No: 1, Text Type: N, H10
[48631728]
Approximately one hour into the procedure the surgeon began to complain of an increase in bubbles and warming of the hand piece. It was determined that the probe was broken. The broken probe was replaced with a new shock pulse probe. This improved the bubbles and the procedure was completed using the new probe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5764573 |
| MDR Report Key | 5764573 |
| Date Received | 2016-07-01 |
| Date of Report | 2016-06-29 |
| Date of Event | 2016-06-27 |
| Report Date | 2016-06-29 |
| Date Reported to FDA | 2016-06-29 |
| Date Reported to Mfgr | 2016-06-29 |
| Date Added to Maude | 2016-07-01 |
| 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 | OLYMPUS SHOCKPULSE SE |
| Generic Name | LITHOTRIPTOR, ULTRASONIC |
| Product Code | FEO |
| Date Received | 2016-07-01 |
| Catalog Number | SPL-PD376 |
| Lot Number | W1605154 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS SURGICAL |
| Manufacturer Address | 2400 RINGWOOD AVENUE SAN JOSE CA 95131 US 95131 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-01 |