MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1997-03-14 for STORZ PATON DOUBLE ENDED SPATULA E3046 manufactured by Storz Insteument Co..
[45883]
During a photorefractive keratectomy (prk) procedure, the physician noted that using this spatula caused more sufgace irregularity that what was expected. Upon inspection of the device, a split was noted on the spoon end of the spatula.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1932180-1997-00030 |
| MDR Report Key | 76989 |
| Report Source | 06 |
| Date Received | 1997-03-14 |
| Date of Report | 1997-02-10 |
| Date of Event | 1996-11-15 |
| Date Facility Aware | 1996-11-15 |
| Report Date | 1997-02-10 |
| Date Reported to Mfgr | 1997-02-10 |
| Date Mfgr Received | 1997-02-10 |
| Date Added to Maude | 1997-03-20 |
| 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 | 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 PATON DOUBLE ENDED SPATULA |
| Generic Name | OPHTHALMIC SPATULA |
| Product Code | HND |
| Date Received | 1997-03-14 |
| Model Number | NA |
| Catalog Number | E3046 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3.5 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 76709 |
| Manufacturer | STORZ INSTEUMENT CO. |
| Manufacturer Address | 499 SOVEREIGN CT. ST LOUIS MO 63011 US |
| Baseline Brand Name | STORZ PATON DOUBLE ENDED SPATULA |
| Baseline Generic Name | OPHTHALMIC SPATULA |
| Baseline Model No | NA |
| Baseline Catalog No | E3046 |
| Baseline ID | NA |
| Baseline Device Family | OPHTHALMIC SPATULA |
| 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 | 1997-03-14 |