MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1996-09-23 for STORZ KELLY MEMBRANE DECEMET PUNCH E2798 manufactured by Storz Instrument Co..
[16764002]
During a cataract extraction procedure, this instrument broke. The physician was able to retrieve the broken piece from the patient's eye. There were no patient problems.
Patient Sequence No: 1, Text Type: D, B5
[16979975]
Sections a through f were completed by the mfr. Date entered in section f. 13 is the date the description of the failure was received. Outside shaft at tip has some material broken off. Tip of punch is bent. The material may have broken off when the handle was squeezed when operated. The cause for the bend is not known.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1932180-1996-00074 |
| MDR Report Key | 41665 |
| Report Source | 05,06 |
| Date Received | 1996-09-19 |
| Date of Report | 1996-08-20 |
| Date of Event | 1996-08-14 |
| Date Facility Aware | 1996-08-14 |
| Date Reported to Mfgr | 1996-08-20 |
| Date Mfgr Received | 1996-08-20 |
| Date Added to Maude | 1996-10-10 |
| 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 MEMBRANE DECEMET PUNCH |
| Generic Name | CORNEO-SCLERAL PUNCH |
| Product Code | HNJ |
| Date Received | 1996-09-23 |
| Model Number | NA |
| Catalog Number | E2798 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 42722 |
| Manufacturer | STORZ INSTRUMENT CO. |
| Manufacturer Address | 499 SOVEREIGN CT 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 | 1996-09-19 |