MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-09-26 for GLIDERITE RIGID STYLET 0800-0309 manufactured by Verathon Medical Ulc.
[87871884]
The stylet used during the procedure was not retained by the customer and therefore not returned to verathon for evaluation; however, two (2) rigid stylets with cracked handles were returned to verathon europe for evaluation. A visual inspection of the returned stylets was performed, cracking on the handles of the stylets was confirmed. In addition, it was noted that some of the plastic on one of the returned stylet handles was missing. The date code stamped onto the handles of the returned stylets indicated the handles of the stylets were molded in 2009. 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. The facility did not disclose how many sterilization cycles the stylets have gone through. A verathon europe customer care representative discussed with the customer the cleaning instructions as outlined in the omm. Because the lot number of the stylet used during the procedure was not known and the number of sterilization cycles the stylet went through was not reported, the exact cause could not be conclusively determined. However; based upon the samples returned from the customer it is likely the age and sterilization cycles may have contributed to the cracking of the plastic handles. Corrective action is not required at this time.
Patient Sequence No: 1, Text Type: N, H10
[87871885]
The customer reported that during a patient procedure, using a gliderite rigid stylet, the blue plastic handle of the stylet detached and fell onto the floor. No delay in the procedure or use of a back-up device was reported. No harm to patient or user was reported. The rigid stylet used in the procedure was not retained; however, the customer has two (2) additional rigid stylets with cracks noted on the blue handles.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615393-2017-00171 |
| MDR Report Key | 6896184 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-09-26 |
| Date of Report | 2017-08-29 |
| Date of Event | 2017-08-29 |
| Date Mfgr Received | 2017-08-29 |
| Date Added to Maude | 2017-09-26 |
| 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 | 2017-09-26 |
| Returned To Mfg | 2017-08-31 |
| Model Number | 0800-0309 |
| Catalog Number | 0800-0309 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2017-09-26 |