MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-03-02 for INNER SHEATH WITH CERAMIC BEAK 27050CA manufactured by Karl Storz Se & Co. Kg.
[139049999]
The device was evaluated. The ceramic tip was broken off. Damage is most likely due to the ceramic beak making contact with a hard surface, causing an internal crack and resulting in the breakage; we cannot confirm.
Patient Sequence No: 1, Text Type: N, H10
[139050000]
Allegedly, during a turp procedure, the ceramic tip of the sheath broke off into the patient. They were unable to quickly retrieve the broken piece and, due to patient's excessive bleeding, they decided to wait until bleeding stopped to perform a subsequent procedure to retrieve the piece, which was performed four days later. There was no harm to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610617-2019-00026 |
| MDR Report Key | 8384584 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-02 |
| Date of Report | 2018-11-13 |
| Date of Event | 2018-11-09 |
| Date Mfgr Received | 2018-11-13 |
| Device Manufacturer Date | 2017-06-01 |
| Date Added to Maude | 2019-03-02 |
| 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 SE & CO. KG |
| Manufacturer Street | DR.-KARL-STORZ-STRASSE 34 78532 |
| Manufacturer City | TUTTLINGEN, |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INNER SHEATH WITH CERAMIC BEAK |
| Generic Name | INNER RESECTOSCOPE SHEATH |
| Product Code | FBO |
| Date Received | 2019-03-02 |
| Returned To Mfg | 2018-12-21 |
| Model Number | 27050CA |
| Catalog Number | 27050CA |
| Lot Number | TS04 |
| 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 | 2019-03-02 |