MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-01-23 for JAWZ ENDOMYOCARDIAL BIOPSY FORCEP 2.2 MM X 50 CM 190080 manufactured by Argon Medical Devices, Inc..
[3239768]
Device was employed endoscopically for pancreatic lobule biopsy. The device snapped during the procedure when the provider attempted to close the clamp/teeth. No injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5028780 |
| MDR Report Key | 2935597 |
| Date Received | 2013-01-23 |
| Date of Report | 2013-01-23 |
| Date of Event | 2012-12-14 |
| Date Added to Maude | 2013-01-31 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JAWZ ENDOMYOCARDIAL BIOPSY FORCEP 2.2 MM X 50 CM |
| Generic Name | BIOPSY FORCEP |
| Product Code | DWZ |
| Date Received | 2013-01-23 |
| Returned To Mfg | 2013-01-23 |
| Catalog Number | 190080 |
| Lot Number | A32965 |
| ID Number | MFG DATE 09-12 |
| Device Expiration Date | 2017-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARGON MEDICAL DEVICES, INC. |
| Manufacturer Address | 1445 FLAT CREEK ROAD ATHENS TX 75751 US 75751 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-01-23 |