MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-07-30 for BALLENGER SWIVEL KNIFE 66-5015 manufactured by Symmetry Surgical.
[19402897]
No patient information was provided by the initial reporter. The blade came off during a sinus surgery. The blade stuck in the sinus cavity. There was no harm done to the patient. The surgeon chose not to proceed with the surgery. The instrument was thrown away by the facility. No photos were provided. There is no record of purchase. The manufacturer could not be verified. The reporter (materials manager) advised that the instrument was 8-10 years old. The instrument has been used beyond the expected lifetime.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007208013-2014-00010 |
| MDR Report Key | 4118836 |
| Report Source | 06 |
| Date Received | 2014-07-30 |
| Date of Report | 2014-07-29 |
| Date of Event | 2014-05-01 |
| Date Mfgr Received | 2014-05-07 |
| Date Added to Maude | 2014-10-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHRIS SMITH |
| Manufacturer Street | 3034 OWEN DR |
| Manufacturer City | ANTIOCH TN 370130000 |
| Manufacturer Country | US |
| Manufacturer Postal | 370130000 |
| Manufacturer Phone | 6159645392 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BALLENGER SWIVEL KNIFE |
| Generic Name | SWIVEL KNIFE |
| Product Code | KTG |
| Date Received | 2014-07-30 |
| Model Number | 66-5015 |
| Catalog Number | 66-5015 |
| Lot Number | NA |
| ID Number | 00887482119853 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYMMETRY SURGICAL |
| Manufacturer Address | ANTIOCH TN 37013 US 37013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-30 |