MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-08-24 for OLYMPUS 00129 NA manufactured by Olympus Winter & Ibe Gmbh.
[21958130]
The hosp nurse, reading from the pt's chart reported the following: "while trying unsuccessfully to extract a ureteral stone with a ureteral basket, a meatotomy was attempted with scissors. The scissors were placed on the ureteral orifice to effect a cut. The scissors were clamped down on the mucosa and would not release. After some manipulation, the scissors released. " the hosp nurse reported that no tissue damage was caused as a result of the scissors not releasing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610773-1999-00021 |
| MDR Report Key | 238209 |
| Report Source | 05 |
| Date Received | 1999-08-24 |
| Date of Report | 1999-07-26 |
| Date of Event | 1999-07-21 |
| Date Mfgr Received | 1999-07-26 |
| Date Added to Maude | 1999-09-03 |
| 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 | 0 |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Manufacturer Phone | ** |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS |
| Generic Name | FLEXIBLE SCISSORS |
| Product Code | KGD |
| Date Received | 1999-08-24 |
| Model Number | 00129 |
| Catalog Number | NA |
| Lot Number | 16W |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 230841 |
| Manufacturer | OLYMPUS WINTER & IBE GMBH |
| Manufacturer Address | KUEHNSTRASSE 61 HAMBURG GM 22045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-08-24 |