MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2012-05-11 for MID LABS 2540CE manufactured by Medical Instrument Development Laboratories, Inc..
[2712371]
Dr. Tried two cutters of 2540ce both in the same lot and they would not cut. They didn't do anything. They did have pt contact, but no injury. Cutters were tested prior to surgery and worked. When surgery started the cutter sounded like it was working but was not cutting. Aspiration continued. They tried the 20 gauge they had on hand and it worked. They borrowed a 25 gauge from the hosp with a different lot number and they also worked.
Patient Sequence No: 1, Text Type: D, B5
[9889415]
Device eval summary: report: vitreous cutter did not cut. Analysis: vitreous cutter tested and inspected and found to meet specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2935428-2012-00001 |
| MDR Report Key | 2584885 |
| Report Source | 08 |
| Date Received | 2012-05-11 |
| Date of Report | 2012-05-11 |
| Date of Event | 2012-04-12 |
| Date Mfgr Received | 2012-04-13 |
| Device Manufacturer Date | 2011-09-01 |
| Date Added to Maude | 2012-09-20 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 557 MC CORMICK STREET |
| Manufacturer City | SAN LEANDRO CA 94577 |
| Manufacturer Country | US |
| Manufacturer Postal | 94577 |
| Manufacturer Phone | 5103573952 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MID LABS |
| Generic Name | VITREOUS CUTTER |
| Product Code | MLZ |
| Date Received | 2012-05-11 |
| Returned To Mfg | 2012-05-08 |
| Catalog Number | 2540CE |
| Lot Number | 11070508 |
| Device Expiration Date | 2014-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. |
| Manufacturer Address | SAN LEANDRO CA 94577 US 94577 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-05-11 |