MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-05-06 for NONE manufactured by .
[2525467]
Doctor used a diamond knife during ophthalmic surgery for the first time after it had come back from repair, stating that the knife did not slide smoothly and felt that it did not cut the eye correctly. He switched to a disposable knife to complete the procedure. Since two different blades were used, the flaps did not match and did not lie flat. The doctor had to put in a stitch to finish the procedure. The doctor stated that the pt appeared to be ok.
Patient Sequence No: 1, Text Type: D, B5
[9654922]
This initial report was delayed, so that a full eval of the knife could be performed prior to fda notification. Item in question is a 2. 8cc third generation black diamond spear, s/n (b)(4). Upon receipt from the hospital the knife was visually inspected using a microscope at x100. No problem with the knife was discovered. The knife was then shipped to adi (accutome's diamond supplier, also a subsidiary) in the netherlands for further eval. The knife was again visually inspected using a microscope at x100 and x500. Adi was unable to find imperfections in the blade that may have caused the blade not to perform as expected. The black diamond blade on the knife was replaced with a natural diamond at the request of the customer. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2521877-2011-00002 |
| MDR Report Key | 2476131 |
| Report Source | 05,06 |
| Date Received | 2011-05-06 |
| Date of Report | 2011-05-04 |
| Date of Event | 2011-04-11 |
| Date Mfgr Received | 2011-04-18 |
| Device Manufacturer Date | 2011-04-01 |
| Date Added to Maude | 2012-03-05 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 3222 PHOENIXVILLE PIKE |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal | 19355 |
| Manufacturer Phone | 6108890200 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | NONE |
| Product Code | EMF |
| Date Received | 2011-05-06 |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-05-06 |