MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2015-08-21 for GIGLI WIRE SAW FINE6-WIRES400MM SAW FH414 manufactured by Aesculap Ag.
[24670202]
Manufacturing site evaluation: evaluation on-going.
Patient Sequence No: 1, Text Type: N, H10
[24670203]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2015-00737 |
| MDR Report Key | 5032831 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2015-08-21 |
| Date of Report | 2015-08-17 |
| Date Mfgr Received | 2015-07-29 |
| Date Added to Maude | 2015-08-26 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| Manufacturer G1 | AESCULAP AG & CO KG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GIGLI WIRE SAW FINE6-WIRES400MM SAW |
| Generic Name | SAW |
| Product Code | GDR |
| Date Received | 2015-08-21 |
| Model Number | FH414 |
| Catalog Number | FH414 |
| Lot Number | 52119668 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | TUTTLINGEN, DE DE 78532 DE 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-08-21 |