MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-02-25 for CORNEAL TREPHINE BLADE 7.5MM 0009711 manufactured by Medtronic Xomed, Inc..
[1423822]
The attending nurse reported during a corneal transplant procedure, the donor cornea was damaged by the trephine blade and the procedure had to be cancelled until the next day. The transplant was successfully completed, and the pt was discharged. Because the procedure was postponed, which could have caused add'l risk to the pt, the incident is being filed as a mdr.
Patient Sequence No: 1, Text Type: D, B5
[8519821]
Several attempts have been made by medtronic to contact the user facility risk mgr to inquire about the pt info. If add'l info is obtained a f/u report will then be filed. The customer had prepared three different corneal trephine blades for the procedure. While only one blade caused damage to the donor cornea, the customer was unsure which trephine blade was used. Two other separate mdrs (1045254-2010-00006 / 1045254-2010-00007) will be filed for each trephine blade. The facility risk mgr was contacted about the return of the product and she stated that they will not be returning the product to medtronic until the facility has completed their internal investigation of the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2010-00005 |
| MDR Report Key | 1617429 |
| Report Source | 05 |
| Date Received | 2010-02-25 |
| Date of Report | 2010-01-27 |
| Date of Event | 2010-01-25 |
| Date Facility Aware | 2010-01-27 |
| Device Manufacturer Date | 2009-10-01 |
| Date Added to Maude | 2010-03-04 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MIKE MOSBY |
| Manufacturer Street | 6743 SOUTHPOINT DR. NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9042797584 |
| Manufacturer G1 | MEDTRONIC XOMED, INC. |
| Manufacturer Street | 6743 SOUTHPOINT DR. NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CORNEAL TREPHINE BLADE 7.5MM |
| Generic Name | 86 HRH |
| Product Code | HRH |
| Date Received | 2010-02-25 |
| Model Number | 0009711 |
| Catalog Number | 0009711 |
| Lot Number | 64473300 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED, INC. |
| Manufacturer Address | JACKSONVILLE FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-02-25 |