MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-17 for SPL-PD376 manufactured by Olympus.
[45339367]
Patient Sequence No: 1, Text Type: N, H10
[45339368]
Three olympus lithotripsy probes broke before being used. All three of the probes are from the same lot number. They are sending an rma and shipping label to have the device returned for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5658742 |
| MDR Report Key | 5658742 |
| Date Received | 2016-05-17 |
| Date of Report | 2016-04-28 |
| Date of Event | 2016-04-22 |
| Report Date | 2016-04-28 |
| Date Reported to FDA | 2016-04-28 |
| Date Reported to Mfgr | 2016-04-28 |
| Date Added to Maude | 2016-05-17 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 |
| Generic Name | PROBE, LITHOTRIPSY |
| Product Code | FFK |
| Date Received | 2016-05-17 |
| Catalog Number | SPL-PD376 |
| Lot Number | W1504795 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS |
| Manufacturer Address | 3500 CORPORATE PARKWAY CENTER VALLEY PA 18034 US 18034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-17 |