MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-17 for AUTOLITH BIPOLAR ELECTROHYDRAULIC LITHOTRIPTOR PROBE 1.9 FRENCH 250 CM 9-202-2501 manufactured by Northgate Technologies, Inc..
[89625262]
During an ercp with stone retrieval, shl and stent placement procedure, the ehl fiber tip broke off within the bile duct. The tip was not able to be retrieved and the lip felt there was minimal risk to the patient due to the retention of the item.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5072770 |
| MDR Report Key | 6954242 |
| Date Received | 2017-10-17 |
| Date of Report | 2017-10-13 |
| Date of Event | 2017-10-10 |
| Date Added to Maude | 2017-10-17 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Brand Name | AUTOLITH BIPOLAR ELECTROHYDRAULIC LITHOTRIPTOR PROBE |
| Generic Name | EHL PROBE LITHOTRIPTOR |
| Product Code | FFK |
| Date Received | 2017-10-17 |
| Model Number | 1.9 FRENCH 250 CM |
| Catalog Number | 9-202-2501 |
| Lot Number | AT212422 |
| Device Expiration Date | 2019-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NORTHGATE TECHNOLOGIES, INC. |
| Manufacturer Address | ELGIN IL 60123 US 60123 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-17 |