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 2017-06-20 for GLIDERITE RIGID STYLET 0270-0681 manufactured by Verathon Medical Ulc.
[78045920]
The rigid stylet was returned to verathon for evaluation. The detached handle was confirmed. As the lot number of the stylet is unknown the exact date of manufacture is unknown; however, the date code stamped on the stylet handle indicated the handle was molded july 2012. The facility indicated they are using the autoclave sterilization method which is an approved method in the operations and maintenance manual (omm). The omm indicates that exceeding the recommended number of cycles may affect the potential life of the product. The autoclave sterilization method, as indicated in the omm, has been compatibility tested for 300 sterilization cycles; however, the facility indicated they are not tracking the sterilization cycles for the stylet, therefore the cause could not be conclusively determined. Corrective action is not required.
Patient Sequence No: 1, Text Type: N, H10
[78045921]
The customer reported that during a patient procedure, using a gliderite rigid stylet, the stylet handle detached and the stylet slid down the endotracheal tube. A hemostat was used to remove the stylet from the endotracheal tube. No use of a back-up device was reported. No harm to patient or user was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615393-2017-00104 |
| MDR Report Key | 6654896 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-06-20 |
| Date of Report | 2017-05-24 |
| Date of Event | 2017-05-23 |
| Date Mfgr Received | 2017-05-24 |
| Device Manufacturer Date | 2012-07-01 |
| Date Added to Maude | 2017-06-20 |
| 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. 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 | GLIDERITE RIGID STYLET |
| Generic Name | STYLET, TRACHEAL TUBE |
| Product Code | BSR |
| Date Received | 2017-06-20 |
| Returned To Mfg | 2017-05-26 |
| Model Number | 0270-0681 |
| Catalog Number | 0270-0681 |
| Lot Number | UNKNOWN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-06-20 |