MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-03-04 for LARGE STONE GRASPING FORCEPS 27290H manufactured by Karl Storz Gmbh And Co.
[5338671]
Allegedly, doctor was performing a percutaneous nephrolithotomy, when one of the prongs on grasper broke off into pt. The broken grasper was removed from the surgical area and another grasper was used to retrieve the piece in the pt.
Patient Sequence No: 1, Text Type: D, B5
[13048639]
The instrument was not returned for evaluation. Per the customer, device is approximately 10 years old. The device breakage is consistent with stress overload and wear and long usage.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610617-2015-00017 |
| MDR Report Key | 4589626 |
| Report Source | 05,06 |
| Date Received | 2015-03-04 |
| Date of Report | 2015-02-03 |
| Date of Event | 2014-11-11 |
| Date Added to Maude | 2015-04-14 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 AND 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 | LARGE STONE GRASPING FORCEPS |
| Generic Name | GRASPING FORCEPS |
| Product Code | FGA |
| Date Received | 2015-03-04 |
| Model Number | 27290H |
| Catalog Number | 27290H |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ GMBH AND CO |
| Manufacturer Address | TUTTLINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-03-04 |