MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-01-17 for INNER SHEATH 27050CA 27050C manufactured by Karl Storz Se & Co. Kg.
| Report Number | 9610617-2020-00004 |
| MDR Report Key | 9603154 |
| Report Source | USER FACILITY |
| Date Received | 2020-01-17 |
| Date of Report | 2020-01-15 |
| Date Mfgr Received | 2019-11-12 |
| Date Added to Maude | 2020-01-17 |
| 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 | INNER SHEATH |
| Generic Name | UROLOGY RESECTOSCOPE INNER SHEATH |
| Product Code | FBO |
| Date Received | 2020-01-17 |
| Returned To Mfg | 2019-12-11 |
| Model Number | 27050CA |
| Catalog Number | 27050C |
| Lot Number | NU01 |
| 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 | 2020-01-17 |