MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-12-28 for ELITE AND USA COLD KNIFE, STRAIGHT BLADE, 3/PKG K-SB manufactured by Gyrus Acmi Inc..
[14883054]
During a procedure, while using the elite cold knife straight blade, the blade broke off during use in the patient's bladder. The blade was successfully retrieved without any injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
[15167240]
Visual examination of the returned portion (blade only) of the k-sb instrument finds that the blade has broken cleanly from the base of the instrument. The blade exhibits a break profile on the right side of the blade that suggests side loading during use caused the blade to fracture. The fracture originated on the side of the blade, indicating side loading. This device is intended for axial cutting only. The instruction for use manual warns against side loading in the warnings section. The device failed due to abnormal use by the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006159227-2010-00006 |
| MDR Report Key | 1948682 |
| Report Source | 06 |
| Date Received | 2010-12-28 |
| Date of Report | 2010-12-28 |
| Date of Event | 2010-11-29 |
| Date Facility Aware | 2010-11-29 |
| Date Mfgr Received | 2010-11-29 |
| Date Added to Maude | 2012-03-15 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | TERRENCE SULLIVAN |
| Manufacturer Street | 136 T7URNPIKE ROAD |
| Manufacturer City | SOUTHBOROUGH MA 01772 |
| Manufacturer Country | US |
| Manufacturer Postal | 01772 |
| Manufacturer Phone | 5088042739 |
| Manufacturer G1 | GYRUS ACMI INC. |
| Manufacturer Street | CARRETERA SALTILLO-ZACATECAS KM 4.5 LA ANGOSTURA C.P. |
| Manufacturer City | SALTILLO, COAHUILA 25000 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 25000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELITE AND USA COLD KNIFE, STRAIGHT BLADE, 3/PKG |
| Generic Name | COLD KNIFE, STRAIGHT BLADE, 3/PKG |
| Product Code | EZO |
| Date Received | 2010-12-28 |
| Returned To Mfg | 2010-12-22 |
| Model Number | K-SB |
| Catalog Number | K-SB |
| Lot Number | H883KSB07 |
| 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 ACMI INC. |
| Manufacturer Address | CARRETERA SALTILLO-ZACATECAS KM 4.5 LA ANGOSTURA., CP MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-28 |