MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-05-31 for SMART STAPES PISTON .5 X 4.50 MM 70145923 manufactured by Gyrus Acmi, Inc.
[146941759]
The referenced packaging and device were not returned for evaluation. The exact cause of the reported event could not be determined at this time. However, if the device is returned at a later dated, this report will be supplemented accordingly. To mitigate the risk of cross contamination/patient infection, the instructions for use manual cautions users to, "inspect all packages for punctures or evidence of contamination prior to opening. The products will remain sterile in an undamaged, unopened package. "
Patient Sequence No: 1, Text Type: N, H10
[146941760]
Olympus was informed that prior to the start of a stapedectomy procedure, the sterile packaging of the device was inspected and found breached. The procedure was completed with another device of the same lot. There was no adverse outcome to the patient and or procedure reported. The sterile packaging of the device did not exhibit any dents, scratches, etc. Additionally, the user facility reported that the device packaging was inspected upon receipt of the shipment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00897 |
| MDR Report Key | 8660950 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-31 |
| Date of Report | 2019-08-21 |
| Date of Event | 2019-02-19 |
| Date Mfgr Received | 2019-08-15 |
| Device Manufacturer Date | 2016-06-03 |
| Date Added to Maude | 2019-05-31 |
| 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 | 3 |
| Brand Name | SMART STAPES PISTON .5 X 4.50 MM |
| Generic Name | SMART STAPES PISTON |
| Product Code | ETB |
| Date Received | 2019-05-31 |
| Returned To Mfg | 2019-06-03 |
| Model Number | 70145923 |
| Lot Number | MH654624 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-05-31 |