MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2019-01-10 for GLIDESCOPE REUSABLE STYLET 0803-0009 manufactured by Verathon Medical Ulc.
[132992061]
The customer later advised that they had misplaced the glidescope reusable stylet and that it would be returned if found. Pictures of the stylet were provided and evaluated by a verathon complaints specialist. The evaluation determined that the device involved in the incident was an older model stylet which has not been manufactured since 2009, indicating that the customer's stylet is at least 9 years old. Since the stylet was not returned for further evaluation, the exact cause could not be determined. However, based on the last manufacture date of this design and estimated stylet usage, it is likely that the stylet exceeded the approved number of sterilization cycles as indicated in the ifu. Should the device be returned, a supplemental report will be submitted in accordance with 21 cfr 803. 56 with the additional information.
Patient Sequence No: 1, Text Type: N, H10
[132992062]
The customer reported that a piece of their glidescope reusable stylet had broken off during a patient procedure. No delay in the procedure, use of a backup device, or harm to patient or user reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615393-2019-00001 |
| MDR Report Key | 8235250 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2019-01-10 |
| Date of Report | 2018-12-12 |
| Date of Event | 2018-11-29 |
| Date Mfgr Received | 2019-01-31 |
| Date Added to Maude | 2019-01-10 |
| 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, BRITISH COLUMBIA 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 REUSABLE STYLET |
| Generic Name | STYLET, TRACHEAL TUBE |
| Product Code | BSR |
| Date Received | 2019-01-10 |
| Returned To Mfg | 2019-01-31 |
| Model Number | 0803-0009 |
| Catalog Number | 0803-0009 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VERATHON MEDICAL ULC |
| Manufacturer Address | 2227 DOUGLAS ROAD BURNABY, BRITISH COLUMBIA V5C 5A9 CA V5C 5A9 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-10 |