MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-09-26 for BIPOLAR WORKING ELEMENT ONLY W/ SPRING 27040EB manufactured by Karl Storz Se & Co. Kg.
| Report Number | 9610617-2019-00084 |
| MDR Report Key | 9122747 |
| Report Source | USER FACILITY |
| Date Received | 2019-09-26 |
| Date of Report | 2019-09-24 |
| Date of Event | 2019-08-29 |
| Date Mfgr Received | 2019-08-29 |
| Device Manufacturer Date | 2015-04-01 |
| Date Added to Maude | 2019-09-26 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. SUSIE CHEN |
| Manufacturer Street | 2151 E. GRAND AVENUE |
| Manufacturer City | EL SEGUNDO CA 90245 |
| Manufacturer Country | US |
| Manufacturer Postal | 90245 |
| Manufacturer Phone | 4242188201 |
| Manufacturer G1 | KARL STORZ SE & CO.KG |
| Manufacturer Street | DR.-KARL-STORZ -STRASSE 34 78532 |
| Manufacturer City | TUTTLINGEN, GM, |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIPOLAR WORKING ELEMENT ONLY W/ SPRING |
| Generic Name | BI-POLAR RESECTOSCOPE |
| Product Code | FAS |
| Date Received | 2019-09-26 |
| Returned To Mfg | 2019-09-23 |
| Model Number | 27040EB |
| Catalog Number | 27040EB |
| Lot Number | RU05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ SE & CO. KG |
| Manufacturer Address | DR.-KARL-STORZ-STRASSE 34 78532 TUTTLINGEN, GM, |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-09-26 |