MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-05-31 for GLIDESCOPE BFLEX? SINGLE-USE BRONCHOSCOPE SYSTEM 0570-0374 0570-0375 manufactured by Verathon Medical Ulc.
[146671825]
The device return is anticipated, however; at the time of the report the device has not been received by verathon. Verathon continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803. 56 when additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[146671826]
The customer reported that the shaft of their glidescope bflex single-use bronchoscope broke during a patient procedure utilizing a 6mm endotracheal tube. While there was no evidence of separation or material left behind, the end user elected to insert another bronchoscope to perform multiple cross checks in order to verify that no pieces of the bronchoscope were left in the patient. No harm to the patient or user was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615393-2019-00079 |
| MDR Report Key | 8658617 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-05-31 |
| Date of Report | 2019-05-02 |
| Date of Event | 2019-05-02 |
| Date Mfgr Received | 2019-05-02 |
| Device Manufacturer Date | 2019-03-20 |
| Date Added to Maude | 2019-05-31 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. COREY KASBOHM |
| Manufacturer Street | 20001 N CREEK PKWY |
| Manufacturer City | BOTHELL WA 980118218 |
| Manufacturer Country | US |
| Manufacturer Postal | 980118218 |
| Manufacturer Phone | 4256295760 |
| Manufacturer G1 | VERATHON MEDICAL ULC |
| Manufacturer Street | 2227 DOUGLAS ROAD |
| Manufacturer City | BURNABY, V5C 5A9 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | V5C 5A9 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GLIDESCOPE BFLEX? SINGLE-USE BRONCHOSCOPE SYSTEM |
| Generic Name | BRONCHOSCOPE (FLEXIBLE OR RIGID) |
| Product Code | CCW |
| Date Received | 2019-05-31 |
| Model Number | 0570-0374 |
| Catalog Number | 0570-0375 |
| Lot Number | FS190400 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VERATHON MEDICAL ULC |
| Manufacturer Address | 2227 DOUGLAS ROAD BURNABY, V5C 5A9 CA V5C 5A9 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-31 |