MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-17 for HEYMAN NASAL SCISSORS 449002 manufactured by Karl Storz Se & Co. Kg.
[133487775]
The broken instrument was returned for evaluation. We confirmed that one side of the scissors jaw is broken off and was not returned by the facility. The remaining jaw has dents on the edge. The instrument had been in use for almost five years. Damage is most likely due to excessive force and/or handling of the device.
Patient Sequence No: 1, Text Type: N, H10
[133487776]
Allegedly, during a septoplasty procedure, one of the jaws broke off inside the patient. The piece was retrieved and there was not harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610617-2019-00002 |
| MDR Report Key | 8259125 |
| Date Received | 2019-01-17 |
| Date of Report | 2018-12-20 |
| Date of Event | 2018-12-17 |
| Date Mfgr Received | 2018-12-20 |
| Device Manufacturer Date | 2012-06-01 |
| Date Added to Maude | 2019-01-17 |
| 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 EAST GRAND AVENUE |
| Manufacturer City | EL SEGUNDO CA 902455017 |
| Manufacturer Country | US |
| Manufacturer Postal | 902455017 |
| Manufacturer G1 | KARL STORZ SE & CO. KG |
| Manufacturer Street | DR.-KARL-STORZ-STRASSE 34 78532 |
| Manufacturer City | TUTTLINGEN, |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HEYMAN NASAL SCISSORS |
| Generic Name | HEYMAN NASAL SCISSORS |
| Product Code | LRC |
| Date Received | 2019-01-17 |
| Returned To Mfg | 2019-01-07 |
| Model Number | 449002 |
| Catalog Number | 449002 |
| Lot Number | TX01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ SE & CO. KG |
| Manufacturer Address | DR.-KARL-STORZ-STRASSE 34 78532 TUTTLINGEN, GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-01-17 |