MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-03-11 for HOUSE CURRETTE, 17CM OVAL, LG, SPOON 2.2MMX2.5MM 272602 manufactured by Gyrus Acmi Inc..
[19587252]
The user facility reported that during a middle ear surgery, two curette's had the cutting side of the blade break off. The procedure was completed using an unk device. No pt injury reported. Olympus followed up with the user facility to obtain more information but with no results.
Patient Sequence No: 1, Text Type: D, B5
[19819949]
The device reference in this report has not been returned to olympus for evaluation. If additional information or if the device is received at a later time this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2951238-2014-00097 |
| MDR Report Key | 3829869 |
| Report Source | 06 |
| Date Received | 2014-03-11 |
| Date of Report | 2014-02-11 |
| Date of Event | 2014-01-23 |
| Date Mfgr Received | 2014-02-11 |
| Date Added to Maude | 2014-06-13 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | NOEMI SCHAMBACH |
| Manufacturer Street | 2400 RINGWOOD AVE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355002 |
| Manufacturer G1 | GYRUS ACMI INC. |
| Manufacturer Street | 136 TURNPIKE ROAD |
| Manufacturer City | SOUTHBOROUGH MA 01772210 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01772 2104 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOUSE CURRETTE, 17CM OVAL, LG, SPOON 2.2MMX2.5MM |
| Generic Name | CURRETTE |
| Product Code | FZS |
| Date Received | 2014-03-11 |
| Model Number | 272602 |
| Catalog Number | 272602 |
| Lot Number | 03066142/AL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 01772210 US 01772 2104 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 2951238 | 2014-03-11 |