MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-07-30 for MICROKERATOME K-400 378618 manufactured by Bd Ophthalmic Systems.
[19034172]
Microkeratome head field action investigation and corrective action plan. Reported incident: one incident was reported that the microkeratome blade used with a k-4000 microkeratome system stopped oscillating half way over the eye, while continuing to traverse, causing some corneal abrasion. This is the only incident that has been reported. Investigation: the investigation of this incident revealed that there is an interaction between the microkeratome head, part number 378618 and the bearing cartridge (378660), which is inserted into the head and links up with the hand piece motor that causes the blade to oscillate. Due to a worn o-ring, there was sufficient play allowing the bearing cartridge to back off in the head disengaging the blade post, while the blade continued to traverse the eye driven by the traverse motor in the hand piece. Corrective/preventive action: a field action advisory notice will be prepared alerting the user of this potential, and the need to replace the o-ring on a routine basis. The instructions for use will be amended.
Patient Sequence No: 1, Text Type: N, H10
[19050672]
Customer reported that, the blade quit oscillating half way and continued to the end of the pass. Created a half cut across the cornea, scraping the epithelium causing corneal abrasion on second eye. First eye was perfect.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1211998-2007-00001 |
| MDR Report Key | 886410 |
| Report Source | 05 |
| Date Received | 2007-07-30 |
| Date of Report | 2007-07-22 |
| Date of Event | 2007-06-26 |
| Date Mfgr Received | 2007-06-26 |
| Date Added to Maude | 2008-01-08 |
| 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 | DAVID CROMWICK |
| Manufacturer City | WALTHAM MA |
| Manufacturer Country | US |
| Manufacturer Phone | 7819067916 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICROKERATOME |
| Generic Name | MICROKERATOME |
| Product Code | HMY |
| Date Received | 2007-07-30 |
| Returned To Mfg | 2007-06-26 |
| Model Number | K-400 |
| Catalog Number | 378618 |
| ID Number | 378660 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 942529 |
| Manufacturer | BD OPHTHALMIC SYSTEMS |
| Manufacturer Address | WALTHAM MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-07-30 |