MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-10 for OPTIGUIDE? DCYL CYLINDRICAL DIFFUSER manufactured by Pinnacle Biologics, Inc..
[178335539]
Patient in or for a bronchoscopy with photodynamic therapy. Tip of fiber intact before use and was brand new. Surgeon smelled smoke and removed fiber. Laser fiber tip found to have a break in the housing of the catheter where it joined the delivery unit. Patient found to have a small superficial burn in mucosa of the right mainstem bronchus.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9686436 |
| MDR Report Key | 9686436 |
| Date Received | 2020-02-10 |
| Date of Report | 2020-01-20 |
| Date of Event | 2020-01-15 |
| Report Date | 2020-01-20 |
| Date Reported to FDA | 2020-01-20 |
| Date Reported to Mfgr | 2020-02-10 |
| Date Added to Maude | 2020-02-10 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | OPTIGUIDE? DCYL CYLINDRICAL DIFFUSER |
| Generic Name | SYSTEM, LASER, FIBER OPTIC, PHOTODYNAMIC THERAPY |
| Product Code | MVG |
| Date Received | 2020-02-10 |
| Lot Number | 5697801EX 48 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PINNACLE BIOLOGICS, INC. |
| Manufacturer Address | 2801 LAKESIDE DRIVE SUITE 210 BANNOCKBURN IL 60015 US 60015 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-10 |