MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 1997-07-16 for STORZ REUSABLE ERASER D8201 manufactured by Storz Instrument Gmbh.
[67223]
This reusable bipolar erasor would not function during an ophthalmic procedure. Another eraser was used to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010542-1997-00002 |
| MDR Report Key | 106366 |
| Report Source | 06,08 |
| Date Received | 1997-06-16 |
| Date of Report | 1997-06-16 |
| Date of Event | 1997-06-09 |
| Date Facility Aware | 1997-06-09 |
| Report Date | 1997-06-16 |
| Date Reported to Mfgr | 1997-06-16 |
| Date Mfgr Received | 1997-06-16 |
| Date Added to Maude | 1997-07-21 |
| 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 REUSABLE ERASER |
| Generic Name | CAUTERY |
| Product Code | HQR |
| Date Received | 1997-07-16 |
| Model Number | NA |
| Catalog Number | D8201 |
| 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 | 104586 |
| Manufacturer | STORZ INSTRUMENT GMBH |
| Manufacturer Address | IM SCHUHMACHERGEWANN 4 HEIDELBERG GM 69123 |
| Baseline Brand Name | REUSABLE ERASER |
| Baseline Generic Name | APPARATUS, CAUTERY, RADIOFREQUENCY AC POWERED |
| Baseline Model No | NA |
| Baseline Catalog No | D8201 |
| Baseline ID | NA |
| Baseline Device Family | CAUTERY DEVICE |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K952151 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-06-16 |