MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-10-23 for GLIDERITE RIGID STYLET 0270-0681 manufactured by Verathon Medical Ulc.
[168902716]
The gliderite rigid stylet operations and maintenance manual (omm) indicate that the stylet may be sterilized a maximum of 300 cycles at minimum temperature of 134 degrees celsius for 3 minutes to a maximum temperature of 137 degrees celsius for 18 minutes. A verathon complaints specialist contacted the distributor to gather additional information about the customer's use and reprocessing of the stylet. The distributor confirmed that historically the customer has not tracked their stylet usage and therefore unable to provide the number of sterilization cycles they have performed on this stylet. They believed that the stylet was approximately 5 years old and confirmed that the facility uses their stylets multiple times a day. Although the stylet was not returned to verathon for evaluation, it is likely that the device had exceeded the maximum 300 sterilization cycles per the omm. The customer informed the distributor that they have implemented a procedure to track the usage of their stylets. The customer was also provided with a copy of the omm and indicated that they will be following the sterilization steps and limits going forward. Corrective action is not required at this time. Verathon will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
[168902717]
It was reported by a distributor on behalf of the customer, that the handle of their gliderite rigid stylet had broken during a procedure. It was noted that forceps were needed to remove the device from the endotracheal (et) tube. No harm to the patient or user was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615393-2019-00141 |
| MDR Report Key | 9224005 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2019-10-23 |
| Date of Report | 2019-09-24 |
| Date of Event | 2019-09-24 |
| Date Mfgr Received | 2019-09-24 |
| Date Added to Maude | 2019-10-23 |
| 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 | 2019-10-23 |
| Model Number | 0270-0681 |
| Catalog Number | 0270-0681 |
| Lot Number | UNKNOWN |
| 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 | 2019-10-23 |