MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-06 for NASAL SCISSORS 449403 manufactured by Karl Storz Gmbh & Co. Kg Tuttlingen, Germany.
[30884987]
The device is not being returned to us at this time; the hospital is still conducting their own investigation. The mdr listed date code as da (4/2009); we found a record of this being shipped to the customer on 01/07/2010; instrument has been in use for approximately 5+ years.
Patient Sequence No: 1, Text Type: N, H10
[30884988]
Allegedly, the doctor was performing an endo-nasal ethmoidectomy fusion navigation procedure, one of the blades broke off inside the sinus passage. The doctor immediately removed it. The procedure was completed with no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610617-2015-00094 |
| MDR Report Key | 5208417 |
| Date Received | 2015-11-06 |
| Date of Report | 2015-10-08 |
| Date of Event | 2015-09-22 |
| Date Mfgr Received | 2015-10-08 |
| Date Added to Maude | 2015-11-06 |
| 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 | NASAL SCISSORS |
| Generic Name | NASAL SCISSORS |
| Product Code | KBD |
| Date Received | 2015-11-06 |
| Model Number | 449403 |
| Catalog Number | 449403 |
| Lot Number | DA |
| 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 | 1. Required No Informationntervention | 2015-11-06 |