FDA Adverse Event
Malfunction
Summary report: N
GIGLI WIRE SAW FINE6-WIRES400MM SAW
MDR report key: 5032831
·
Received August 21, 2015
Report
- Report Number
- 2916714-2015-00737
- Event Type
- Malfunction
- Date Received
- August 21, 2015
- Report Date
- August 17, 2015
- Manufacturer
- AESCULAP AG
- Product Code
- GDR
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.
Description of Event or Problem · 1
COUNTRY OF COMPLAINT: (B)(6). DURING A PROCEDURE, THE HANDLE LOOP DETACHED FROM ONE END OF BOTH GIGLI SAWS 40 CM. TO CONCLUDE THE PROCEDURE, 2 X 30 CM GIGLI SAWS WERE USED BUT THEY ALSO CAME APART AT THE HANDLE LOOP. THESE INSTRUMENTS ARE REPLACED AFTER EACH USE. TWO DEVICES USED IN THIS PROCEDURE WERE REPORTED UNDER MEDWATCH 2916714-2015-00519 AND 2916714-2015-00520.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 555367 | GIGLI WIRE SAW FINE6-WIRES400MM SAW | SAW | GDR | AESCULAP AG | FH414 | 52119668 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |