MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-03-04 for STORZ FENZL IRIS RETRACTOR E0755 manufactured by Storz Instrument Co..
[44291]
During an cataract edtraction procedure, the tip of this iris retractor broke as soon as the surgeon began to use it. The broken piece was retrieved but lost. There was no pt injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1932180-1997-00027 |
| MDR Report Key | 74119 |
| Report Source | 05,06 |
| Date Received | 1997-03-04 |
| Date of Report | 1997-02-03 |
| Date of Event | 1997-02-03 |
| Date Facility Aware | 1997-02-03 |
| Report Date | 1997-02-03 |
| Date Reported to Mfgr | 1997-02-03 |
| Date Mfgr Received | 1997-02-03 |
| Date Added to Maude | 1997-03-10 |
| 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 FENZL IRIS RETRACTOR |
| Generic Name | OPHTHALMIC RETRACTOR |
| Product Code | HNI |
| Date Received | 1997-03-04 |
| Model Number | NA |
| Catalog Number | E0755 |
| 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 | 73949 |
| Manufacturer | STORZ INSTRUMENT CO. |
| Manufacturer Address | 499 SOVEREIGN CT. ST. LOUIS MO 63011 US |
| Baseline Brand Name | STORZ FENZL IRIS RETRACTOR |
| Baseline Generic Name | IRIS RETRACTOR |
| Baseline Model No | NA |
| Baseline Catalog No | E0755 |
| Baseline ID | * |
| Baseline Device Family | OPHTHALMIC RETRACTOR |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-03-04 |