MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-06-29 for SEMI-RIGID GRASPING FORCEPS 27023FM SAME manufactured by Karl Storz Gmbh & Co. Kg.
[6540929]
Allegedly, during ureteroscopy procedure the forceps broke. The doctor removed the forceps after which a small metal piece from the forceps was seen in the ureter and it was flushed out. There was no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
[14498730]
We evaluated the forceps and found that the linkage that attaches to hinge is missing. Damage is most likely due to stress overload.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610617-2015-00046 |
| MDR Report Key | 4892566 |
| Report Source | 05,06 |
| Date Received | 2015-06-29 |
| Date of Report | 2015-06-12 |
| Date of Event | 2015-06-11 |
| Device Manufacturer Date | 2015-03-01 |
| Date Added to Maude | 2015-07-07 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SUSIE CHEN |
| Manufacturer Street | 2151 E. GRAND AVE |
| Manufacturer City | EL SEGUNDO CA 902455017 |
| Manufacturer Country | US |
| Manufacturer Postal | 902455017 |
| Manufacturer Phone | 4242188201 |
| Manufacturer G1 | KARL STORZ GMBH & CO. KG |
| Manufacturer Street | MITTELSTRASSE 8 |
| Manufacturer City | TUTTLINGEN 78503 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78503 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SEMI-RIGID GRASPING FORCEPS |
| Generic Name | GRASPING FORCEPS |
| Product Code | FGC |
| Date Received | 2015-06-29 |
| Returned To Mfg | 2015-06-18 |
| Model Number | 27023FM |
| Catalog Number | SAME |
| Lot Number | PU |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ GMBH & CO. KG |
| Manufacturer Address | MITTELSTRASSE 8 TUTTLINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-29 |