MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-01-17 for GRASPING FORCEPS FOR LARGE STONE 27290K manufactured by Karl Storz Se & Co. Kg.
[133526133]
The device was not returned for evaluation. Damage is most likely due to stress overload. The instrument had been in use for over seven years.
Patient Sequence No: 1, Text Type: N, H10
[133526134]
Allegedly, during a pcnl procedure, one of the jaws of the stone grasping forceps broke off inside the patient. The broken jaw was retrieved. There was no harm to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610617-2019-00011 |
| MDR Report Key | 8259130 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-01-17 |
| Date of Report | 2018-11-08 |
| Date of Event | 2018-11-08 |
| Device Manufacturer Date | 2010-09-01 |
| 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 E. GRAND AVENUE |
| Manufacturer City | EL SEGUNDO CA 902455017 |
| Manufacturer Country | US |
| Manufacturer Postal | 902455017 |
| Manufacturer Phone | 4242188201 |
| 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 | 3 |
| Brand Name | GRASPING FORCEPS FOR LARGE STONE |
| Generic Name | STONE GRASPING FORCEPS |
| Product Code | FGA |
| Date Received | 2019-01-17 |
| Model Number | 27290K |
| Catalog Number | 27290K |
| Lot Number | WZ01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 |