MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,08 report with the FDA on 1997-01-17 for STORZ KELLY DECEMET MEMBRANE PUNCH E2798 manufactured by Storz Instrument Company.
[42676]
This instrment was received in february 1996. They have become rusty and particles of rust have fallen into the eye during procedures.
Patient Sequence No: 1, Text Type: D, B5
[16980863]
Improper cleaning has been determined to be the cause of this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1932180-1997-00009 |
| MDR Report Key | 64487 |
| Report Source | 05,06,08 |
| Date Received | 1997-01-17 |
| Date of Report | 1996-12-18 |
| Date of Event | 1996-11-15 |
| Date Facility Aware | 1996-11-15 |
| Report Date | 1996-12-18 |
| Date Reported to Mfgr | 1996-12-18 |
| Date Mfgr Received | 1996-12-18 |
| Date Added to Maude | 1997-01-27 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STORZ KELLY DECEMET MEMBRANE PUNCH |
| Generic Name | MEMBRANE PUNCH |
| Product Code | HNJ |
| Date Received | 1997-01-17 |
| Model Number | NA |
| Catalog Number | E2798 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 12 MO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 64611 |
| Manufacturer | STORZ INSTRUMENT COMPANY |
| Manufacturer Address | 499 SOVEREIGN COURT ST LOUIS MO 63011 US |
| Baseline Brand Name | KELLY DECEMET MEMBRANE PUNCH |
| Baseline Generic Name | CORNEO-SCLERAL PUNCH |
| Baseline Model No | NA |
| Baseline Catalog No | E2798 |
| Baseline ID | * |
| Baseline Device Family | OPHTHALMIC PUNCH |
| Baseline Shelf Life Contained | A |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-01-17 |