MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-04-16 for ELITE & USA COLD KNIFE, SERRATED BLADE K-SE manufactured by Gyrus Medical Inc..
[22050583]
The complaint has been confirmed. The electrode has been returned with the knife blade fractured off. The blade fractured at the distal end of the electrode. All parts are accounted for. The weld site is intact. The blade has a slight bend to the proximal end at the fracture point. This would indicate that a sideways force was applied to the blade prior to it fracturing off. The blade of the electrode showed signs of excessive force bending it, the user caused the failure mode.
Patient Sequence No: 1, Text Type: N, H10
[22103124]
During a surgical procedure for a right ureteral stricture and ureteral stent, the knife blade on the cold knife broke off and fell into the patient's bladder. All pieces were recovered with no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183680-2009-00029 |
| MDR Report Key | 1374599 |
| Report Source | 06 |
| Date Received | 2009-04-16 |
| Date of Report | 2009-04-16 |
| Date of Event | 2009-03-31 |
| Date Facility Aware | 2009-03-31 |
| Date Mfgr Received | 2009-03-31 |
| Date Added to Maude | 2010-03-03 |
| 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 | TERRENCE SULLIVAN |
| Manufacturer Street | 136 TURNPIKE RD. |
| Manufacturer City | SOUTHBOROUGH MO 01772 |
| Manufacturer Country | US |
| Manufacturer Postal | 01772 |
| Manufacturer Phone | 5088042739 |
| Manufacturer G1 | GYRUS MEDICAL INC. |
| Manufacturer Street | 6655 WEDGWOOD ROAD |
| Manufacturer City | MAPLE GROVE MN 55311360 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55311 3602 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELITE & USA COLD KNIFE, SERRATED BLADE |
| Generic Name | COLD KNIFE, SERRATED BLADE, 3/PKG. |
| Product Code | EZO |
| Date Received | 2009-04-16 |
| Returned To Mfg | 2009-04-13 |
| Model Number | K-SE |
| Catalog Number | K-SE |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS MEDICAL INC. |
| Manufacturer Address | MAPLE GROVE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-04-16 |