MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-19 for CYSTO-URETHROSCOPE SHEATH 27026BA manufactured by Karl Storz Gmbh & Co. Kg Tuttlingen, Germany.
[46672302]
We evaluated the instrument and confirmed that the tip had come off the instrument. Under magnification, part of the metal looked torn; possible stress overload as cause, but we cannot confirm.
Patient Sequence No: 1, Text Type: N, H10
[46672303]
Allegedly, the doctor was performing a cystoscopy fulguration on a male patient when the tip of the sheath separated from the device in the patient; the doctor retrieved the piece. This caused a 60 minute delay; the delay did not cause injury to the patient. Procedure was completed with no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610617-2016-00087 |
| MDR Report Key | 5668109 |
| Date Received | 2016-05-19 |
| Date of Report | 2016-04-19 |
| Date of Event | 2016-04-15 |
| Date Mfgr Received | 2016-04-19 |
| Device Manufacturer Date | 2013-05-01 |
| Date Added to Maude | 2016-05-19 |
| 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 | 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-URETHROSCOPE SHEATH |
| Generic Name | CYSTO SHEATH |
| Product Code | ODB |
| Date Received | 2016-05-19 |
| Returned To Mfg | 2016-04-28 |
| Model Number | 27026BA |
| Catalog Number | 27026BA |
| Lot Number | SW |
| 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, GERMANY, GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-05-19 |