MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-14 for AUTOLITH IEHL 9-200-00 manufactured by Northgate Technologies Inc..
[42630567]
Patient Sequence No: 1, Text Type: N, H10
[42630568]
During ercp procedure, md was ready to use the lithotripsy to blast a stone. The nurse connected the catheter from the lithotripsy machine but the prompt kept saying to "connect the probe". All connections were rechecked without success. Biomed was called and machine was taken out of the room. Equipment was immediately taken out of service. We have ordered a new autolith and expect it to arrive on 3/8/2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5575927 |
| MDR Report Key | 5575927 |
| Date Received | 2016-04-14 |
| Date of Report | 2016-03-09 |
| Date of Event | 2016-02-24 |
| Report Date | 2016-03-09 |
| Date Reported to FDA | 2016-03-09 |
| Date Reported to Mfgr | 2016-03-09 |
| Date Added to Maude | 2016-04-14 |
| 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 | AUTOLITH |
| Generic Name | LITHOTRIPTOR, ELECTRO-HYDRAULIC |
| Product Code | FFK |
| Date Received | 2016-04-14 |
| Model Number | IEHL 9-200-00 |
| ID Number | 08331 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NORTHGATE TECHNOLOGIES INC. |
| Manufacturer Address | 1591 SCOTTSDALE COURT ELGIN, IL 60123 US 60123 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-14 |