MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-28 for STONEBREAKER SINGLE USE PROBE SBP-010605 manufactured by Cook Inc.
[103949837]
Common name/ product code: lithotriptor, electro-hydraulic/ ffl. Pma/510(k) #: k062475. (b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[103949838]
It was reported when gathering products for a recall response, a hair was observed in the sterile package of this stonebreaker single use probe. There were no adverse consequences to the patient as a result of this reported issue. The device did not make contact with the patient.
Patient Sequence No: 1, Text Type: D, B5
[113065359]
Investigation? Evaluation: a visual inspection of the returned device was conducted. A review of complaint history, the device history record, quality control data and specifications was also performed. One unopened package labeled rpn (b)(4), label lot number 7030045 was received. Visual examination of the sealed package confirmed a dark colored hair loose inside the sealed package. Review of the device history record found no non-conformances associated with the reported failure mode. A review of complaint history revealed there are no other complaints associated with the complaint product lot number 7030045. A document review was carried out and it was identified that the product line was inspected for foreign matter after being packaged. There were no additional complaints or non-conformances identified on the same lot. The cause of this complaint is manufacturing related. Measures have been initiated to address this failure. Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2018-00812 |
| MDR Report Key | 7377182 |
| Date Received | 2018-03-28 |
| Date of Report | 2018-06-07 |
| Date Mfgr Received | 2018-06-06 |
| Device Manufacturer Date | 2016-06-08 |
| Date Added to Maude | 2018-03-28 |
| 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 | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STONEBREAKER SINGLE USE PROBE |
| Product Code | FFK |
| Date Received | 2018-03-28 |
| Catalog Number | SBP-010605 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-28 |