MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-01-17 for STORZ LIGHT PIPE 20 GAUGE MVS1011A manufactured by Storz Instrument Co..
[42000]
During a vitreo retinal procedure, the physician reported that the length of the procedure was increased approx. Two hrs because there was insufficient light coming from this lite pipe. Three different lite pipes, from different lots, were tried and all had different degrees of dark spots. There was no adverse effect on the pt.
Patient Sequence No: 1, Text Type: D, B5
[7830986]
Design revisions are being considered to reduce the shadows being produced by this device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1920664-1997-00046 |
| MDR Report Key | 64617 |
| Report Source | 05,06 |
| Date Received | 1997-01-17 |
| Date of Report | 1996-12-19 |
| Date of Event | 1996-12-18 |
| Date Facility Aware | 1996-12-18 |
| Report Date | 1996-12-19 |
| Date Reported to Mfgr | 1996-12-19 |
| Date Mfgr Received | 1996-12-19 |
| Device Manufacturer Date | 1996-06-01 |
| Date Added to Maude | 1997-01-28 |
| 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 LIGHT PIPE 20 GAUGE |
| Generic Name | LIGHT PIPE |
| Product Code | HBI |
| Date Received | 1997-01-17 |
| Model Number | NA |
| Catalog Number | MVS1011A |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 64740 |
| 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 | 1997-01-17 | |
| 2 | 0 | 1997-01-17 |