MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-19 for 25GA/0.5 MM STEPPED ILLUMINATING LASER PROBE 7625.ALCU manufactured by Peregrine Surgical, Ltd..
[98186765]
The 25ga curved illuminating laser probe stopped working during case resulting in surgical treatment delay. Manufacturer will work with current inventory (unused samples) to try to recreate failure to determine cause.
Patient Sequence No: 1, Text Type: N, H10
[98186766]
During a surgical case a 25ga curved illuminating laser probe (7625. Alcu lot # 739402) was being used with the following parameters, 250,200,50. After a minute of laser used an audible "pop" sound was heard, the laser stopped working, and smoke was observed emanating from the tip two other probes from the same lot were tried with the same result. The case was halted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2529392-2018-00001 |
| MDR Report Key | 7206541 |
| Date Received | 2018-01-19 |
| Date of Report | 2018-01-19 |
| Date of Event | 2018-01-15 |
| Date Mfgr Received | 2018-01-18 |
| Device Manufacturer Date | 2017-10-19 |
| Date Added to Maude | 2018-01-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MS JAYNE GUTHRIE |
| Manufacturer Street | 51 BRITAIN DRIVE |
| Manufacturer City | NEW BRITAIN PA 18901 |
| Manufacturer Country | US |
| Manufacturer Postal | 18901 |
| Manufacturer Phone | 2153480456 |
| Manufacturer G1 | PEREGRINE SURGICAL, LTD. |
| Manufacturer Street | 51 BRTIAIN DRIVE |
| Manufacturer City | NEW BRITAIN PA 18901 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 18901 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 25GA/0.5 MM STEPPED ILLUMINATING LASER PROBE |
| Generic Name | 25GA CURVED ILLUMINATING LASER PROBE |
| Product Code | HQB |
| Date Received | 2018-01-19 |
| Model Number | 7625.ALCU |
| Catalog Number | 7625.ALCU |
| Lot Number | 739402 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PEREGRINE SURGICAL, LTD. |
| Manufacturer Address | 51 BRITAIN DRIVE NEW BRITAIN PA 18901 US 18901 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-01-19 |