MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-21 for CYSTYO-URETHROSCOPE SHEATH 27026BA manufactured by Karl Storz Gmbh & Co. Kg Tuttlingen, Germany.
[44024297]
Device not released by hospital.
Patient Sequence No: 1, Text Type: N, H10
[44024298]
Allegedly, during a cystoscopy (left retrograde pyelogram, left ureteral stent placement) the distal end of instrument broke off into patient. The broken piece was retrieved. The patient received an abrasion to the prostatic urethra; a foley catheter was inserted. The doctor states the abrasion will heal on its own. The procedure was completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610617-2016-00071 |
| MDR Report Key | 5596314 |
| Date Received | 2016-04-21 |
| Date of Report | 2016-03-22 |
| Date of Event | 2016-03-17 |
| Date Mfgr Received | 2016-03-22 |
| Date Added to Maude | 2016-04-21 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 902455017 |
| Manufacturer Country | US |
| Manufacturer Postal | 902455017 |
| Manufacturer Phone | 4242188201 |
| Manufacturer G1 | KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY |
| Manufacturer Street | MITTLESTRASSE 8, 78503 |
| Manufacturer City | TUTTLINGEN, GERMANY, |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CYSTYO-URETHROSCOPE SHEATH |
| Generic Name | CYSTO SHEATH |
| Product Code | FBO |
| Date Received | 2016-04-21 |
| Model Number | 27026BA |
| Catalog Number | 27026BA |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY |
| Manufacturer Address | MITTLESTRASSE 8, 78503 TUTTLINGEN, GERMANY, GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-04-21 |