MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-03-21 for STORZ 20 GAUGE LIGHT PIPES MVS1011A manufactured by Storz Instrument Co..
[49980]
Ophthalmic procedure (approx. 15 to 20) were extended from 30 minutes to over an hr because of shadows that appear on the surgical field. All procedures were able to be completed by maneuvering the light pipe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1920664-1997-00152 |
| MDR Report Key | 78233 |
| Report Source | 05,06 |
| Date Received | 1997-03-21 |
| Date of Report | 1997-02-06 |
| Date of Event | 1997-01-08 |
| Date Facility Aware | 1997-01-08 |
| Report Date | 1997-02-21 |
| Date Reported to Mfgr | 1997-02-21 |
| Date Mfgr Received | 1997-02-21 |
| Date Added to Maude | 1997-03-27 |
| 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 20 GAUGE LIGHT PIPES |
| Generic Name | SURGICAL FIELD FIBEROPTIC ILLUMINATOR |
| Product Code | HBI |
| Date Received | 1997-03-21 |
| Model Number | NA |
| Catalog Number | MVS1011A |
| 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 | 77865 |
| Manufacturer | STORZ INSTRUMENT CO. |
| Manufacturer Address | 3365 TREE COURT IND BLVD ST. LOUIS MO 63122 US |
| Baseline Brand Name | STORZ LIGHT PIPE, 20 GAUGE, 6/BOX |
| Baseline Generic Name | FIBEROPTIC ENDOILLUMINATOR |
| Baseline Model No | NA |
| Baseline Catalog No | MVS1011A |
| Baseline ID | NA |
| Baseline Device Family | LIGHT PIPE |
| Baseline Shelf Life Contained | N |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K896549 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-03-21 |