FDA Adverse Event
Malfunction
Summary report: N
GIGLI WIRE SAW FINE 6-WIRES500MM
MDR report key: 4963922
·
Received July 30, 2015
Report
- Report Number
- 2916714-2015-00651
- Event Type
- Malfunction
- Date Received
- July 30, 2015
- Report Date
- July 30, 2015
- Manufacturer
- AESCULAP AG
- Product Code
- GDR
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LO
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
U.S. REPORTING AGENT NOTIFIED ON: (B)(6) 2015. MANUFACTURING SITE EVALUATION.
Description of Event or Problem · 1
COUNTRY OF COMPLAINT: (B)(6). INADEQUATE QUALITY OF THE MATERIAL DURING FIRST USE. METAL SHAVINGS LEFT IN THE WOUND, WHICH CAUSED ARTIFACTS DURING EXAMINATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 498810 | GIGLI WIRE SAW FINE 6-WIRES500MM | CRANIAL SAW | GDR | AESCULAP AG | FH415 | 52118162 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |