MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-26 for CYSTOSCOPE-URETHROSCOPE SHEATH 27026CB manufactured by Karl Storz Gmbh & Co. Kg Tuttlingen, Germany.
[74021347]
Allegedly, during a cystoscopy procedure the doctor noted that a piece of the ceramic beak broke off the instrument and fell into the patient's bladder. The doctor conducted an open procedure for removal of retained foreign object. The procedure was completed with no delay. The hospital reported there was no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610617-2017-00035 |
| MDR Report Key | 6524014 |
| Date Received | 2017-04-26 |
| Date of Report | 2017-03-29 |
| Date of Event | 2017-03-09 |
| Date Mfgr Received | 2017-03-29 |
| Device Manufacturer Date | 2013-07-01 |
| Date Added to Maude | 2017-04-26 |
| 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 | 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 | 4242188519 |
| 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 | CYSTOSCOPE-URETHROSCOPE SHEATH |
| Generic Name | CYSTOSCOPE-URETHROSCOPE SHEATH |
| Product Code | ODB |
| Date Received | 2017-04-26 |
| Model Number | 27026CB |
| Catalog Number | 27026CB |
| Lot Number | UW |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-04-26 |