MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-20 for AUTOLITH TOUCH EHL PROBE M00546620 72-00322-0 manufactured by Northgate Technologies Inc..
[90771696]
Nti was made aware of an issue from customer (b)(6) where it was alleged that the "probe was not breaking up the stone". Further information was provided to northgate in the complaint for "burning smell". This report is being filed for the "burning smell" issue. The complaint originated from (b)(6) hospital. The probe was returned to northgate technologies with the connector disconnected, so the device could not be assessed fully for proper function. The probe had a kink adjacent to the kynar sleeve, of unknown origin. The connector was not connected to the probe and seems to be have been separated from the rest of the probe. After viewing the probe under the microscope, there seemed to be possible evidence of charring at the separation of the probe from the connector. The discolored portion underneath the kynar is due to loctite (adhesive used during assembly) and not the charring. (b)(4). A device history review was performed, and the lot passed with no indicated failures. Probes are 100% verified by activating the probe for 30 pulses. Per section 7. 3. 5 (e) of the risk assessment for autolith touch/uro-touch/bsc autolith touch & associated ehl disposable probes (nti document number (b)(4)), "probe wires exposed - burn to operator or patient". While the wires were not exposed, a short of some kind appears to have occurred at the connector, as evidenced by the apparent charring at the separation of the probe from the connector. Per the operator's manual under warnings: "electrohydraulic lithotripter probes are limited life, single use devices. If any of the following conditions are noted, regardless of the "replace probe" message, stop using immediately and use a new probe: firing (or arcing) behind the tip, ejection of the tip or insulation material, arcing along the wires or inside/outside the connector. " "! Warning! Do not attempt to reuse a probe once it has been used past 100% of its useful life. "
Patient Sequence No: 1, Text Type: N, H10
[90771697]
On september 21, 2017, northgate technologies was made aware of an event in which it was alleged that during a procedure, "autolith fiber failed to work after several minutes of trying to break up a stone on medium power. Burning smell noticed during the case. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001450997-2017-00002 |
| MDR Report Key | 6965725 |
| Date Received | 2017-10-20 |
| Date of Report | 2017-10-18 |
| Date of Event | 2017-09-19 |
| Date Mfgr Received | 2017-09-21 |
| Device Manufacturer Date | 2017-07-19 |
| Date Added to Maude | 2017-10-20 |
| 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. TODD GATTO |
| Manufacturer Street | 1591 SCOTTSDALE COURT |
| Manufacturer City | ELGIN IL 60123 |
| Manufacturer Country | US |
| Manufacturer Postal | 60123 |
| Manufacturer Phone | 2248562250 |
| Manufacturer G1 | NORTHGATE TECHNOLOGIES INC. |
| Manufacturer Street | 1591 SCOTTSDALE COURT |
| Manufacturer City | ELGIN IL 60123 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60123 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | AUTOLITH TOUCH EHL PROBE |
| Generic Name | BILIARY ELECTROHYDRAULIC LITHOTRIPTER PROBE |
| Product Code | FFK |
| Date Received | 2017-10-20 |
| Returned To Mfg | 2017-09-27 |
| Model Number | M00546620 |
| Catalog Number | 72-00322-0 |
| Lot Number | BSC12771 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-10-20 |