MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-09-15 for LID SPECULUM E4106 ST manufactured by Storz Instrument Company.
[91510]
This speculum broke during a cataract procedure. There was no pt injury. Another speculum was used for the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1932180-1997-00079 |
| MDR Report Key | 120686 |
| Report Source | 05,06 |
| Date Received | 1997-09-15 |
| Date of Report | 1997-08-18 |
| Date of Event | 1997-08-18 |
| Date Facility Aware | 1997-08-18 |
| Report Date | 1997-08-18 |
| Date Reported to Mfgr | 1997-08-18 |
| Date Mfgr Received | 1997-08-18 |
| Date Added to Maude | 1997-09-19 |
| 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 | LID SPECULUM |
| Generic Name | SPECULUM |
| Product Code | HNC |
| Date Received | 1997-09-15 |
| Model Number | NA |
| Catalog Number | E4106 ST |
| 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 | 118319 |
| Manufacturer | STORZ INSTRUMENT COMPANY |
| Manufacturer Address | 499 SOVEREIGN COURT ST LOUIS MO 63011 US |
| Baseline Brand Name | TEMPORAL APPROACH SPEC SOLID |
| Baseline Generic Name | OPHTHALMIC SPECULA |
| Baseline Model No | NA |
| Baseline Catalog No | E4106 ST |
| Baseline ID | NA |
| Baseline Device Family | EYE SPECULUM |
| Baseline Shelf Life Contained | A |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-09-15 |