MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-03-31 for NASAL SCISSORS 449401 manufactured by Karl Storz Gmbh & Co. Kg Tuttlingen, Germany.
[41617589]
Evaluation confirmed that one jaw has broken off the instrument. A probable cause was stress overload; tissue bone possibly too dense. We cannot confirm.
Patient Sequence No: 1, Text Type: N, H10
[41617590]
Allegedly, the doctor was performing an endoscopic nasal procedure and one of the blades broke off the scissors and fell into the patient. The doctor immediately removed it. Per the hospital, the procedure was completed and no injury to the patient was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610617-2016-00032 |
| MDR Report Key | 5540256 |
| Report Source | USER FACILITY |
| Date Received | 2016-03-31 |
| Date of Report | 2016-03-01 |
| Date of Event | 2016-01-22 |
| Date Mfgr Received | 2016-03-01 |
| Device Manufacturer Date | 2013-05-01 |
| Date Added to Maude | 2016-03-31 |
| 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 | 3 |
| Brand Name | NASAL SCISSORS |
| Generic Name | NASAL SCISSORS |
| Product Code | KBD |
| Date Received | 2016-03-31 |
| Returned To Mfg | 2016-03-10 |
| Model Number | 449401 |
| Catalog Number | 449401 |
| 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 | 2016-03-31 |