MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-02-12 for OPTICAL GRASPING FORCEPS * 101350H manufactured by Karl Storz Endoscopy-america, Inc..
[15324049]
During a procedure to remove a thumb tack from a patient's lung, the tip of a long optical grasping forcep broke off and fell into the patient's lung cavity. The thumb tack was removed. The broken tip from the grasper was not visible for removal during the procedure. X-ray shows the grasper tip in the lung post op.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3638689 |
| MDR Report Key | 3638689 |
| Date Received | 2014-02-12 |
| Date of Report | 2014-02-12 |
| Date of Event | 2014-02-06 |
| Report Date | 2014-02-12 |
| Date Reported to FDA | 2014-02-12 |
| Date Reported to Mfgr | 2014-02-21 |
| Date Added to Maude | 2014-02-21 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTICAL GRASPING FORCEPS |
| Generic Name | FORCEPS |
| Product Code | BWH |
| Date Received | 2014-02-12 |
| Model Number | * |
| Catalog Number | 101350H |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| Manufacturer Address | 2151 E. GRAND AVENUE EL SEGUNDO CA 90245501 US 90245 5017 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-12 |