MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-08 for CYSTO-URETHRO SHEATH 27026CA manufactured by Karl Storz Gmbh & Co. Kg Tuttlingen, Germany.
[35701849]
The tip of the instrument was broken off. The tip is braised onto the end of the sheath and upon examination under microscope it was found the soldered connection did not fail; possible cause of the tip breaking off is stress overload or pre-damage, but we cannot confirm.
Patient Sequence No: 1, Text Type: N, H10
[35701850]
Allegedly, during a cystoscopy stricture procedure, the tip of the instrument broke off into patient. The doctor immediately retrieved piece and went on to complete procedure. There was no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610617-2016-00003 |
| MDR Report Key | 5354651 |
| Date Received | 2016-01-08 |
| Date of Report | 2015-12-10 |
| Date of Event | 2015-12-10 |
| Date Mfgr Received | 2015-12-10 |
| Device Manufacturer Date | 2014-07-01 |
| Date Added to Maude | 2016-01-08 |
| 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 |
| 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 | KARL STORZ GMBH 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 | CYSTO-URETHRO SHEATH |
| Generic Name | SHEATH |
| Product Code | ODB |
| Date Received | 2016-01-08 |
| Returned To Mfg | 2015-12-22 |
| Model Number | 27026CA |
| Catalog Number | 27026CA |
| Lot Number | ZY |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY |
| Manufacturer Address | MITTLESTRASSE 8 78503 TUTTLINGEN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-01-08 |