MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-02 for T REUTER BOBBIN W/ MICRON FINISH [ORIG ITEM: 145215] (6/PK) 145215-ENT manufactured by Gyrus Acmi, Inc.
[144133656]
The device was not returned to olympus for evaluation. The cause of the reported event can be attributed to user error as the facility used the device after the expiration date printed on the product label.
Patient Sequence No: 1, Text Type: N, H10
[144133657]
Olympus was informed that during an unknown procedure, an expired micron bobbin ventilation tube was placed in a patient. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00798 |
| MDR Report Key | 8576211 |
| Date Received | 2019-05-02 |
| Date of Report | 2019-05-02 |
| Date of Event | 2019-03-01 |
| Date Mfgr Received | 2019-04-10 |
| Date Added to Maude | 2019-05-02 |
| 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 | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355124 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | T REUTER BOBBIN W/ MICRON FINISH [ORIG ITEM: 145215] (6/PK) |
| Generic Name | T REUTER BOBBIN W/ MICRON |
| Product Code | ETD |
| Date Received | 2019-05-02 |
| Model Number | 145215-ENT |
| Lot Number | 0913375098 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-02 |