MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-04-10 for ELITE & USA COLD KNIFE STRAIGHT BLADE K-SB manufactured by Gyrus Acmi, Inc..
[16873857]
During a surgical procedure while opening the bladder neck of the patient, the tip of the blade on the urethrotome broke off and fell inside the patient's bladder. The broken tip was removed using a flexible biopsy forceps along with a cystoscope. There was no patient injury. The procedure was completed using a resectoscope with a new sterile blade.
Patient Sequence No: 1, Text Type: D, B5
[16999836]
The device has been discarded by the facility. As a result, a determination cannot be made at this time. If further information becomes available, gyrus (b)(4) will continue the investigation and update the agency accordingly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006159227-2012-00006 |
| MDR Report Key | 2536142 |
| Report Source | 06 |
| Date Received | 2012-04-10 |
| Date of Report | 2012-03-19 |
| Date of Event | 2012-02-24 |
| Date Mfgr Received | 2012-03-19 |
| Date Added to Maude | 2012-04-17 |
| 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 | 0 |
| Manufacturer Contact | TERRENCE SULLIVAN |
| Manufacturer Street | 136 TURNPIKE 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 |
| Manufacturer City | LA ANGOSTURA, C.P., 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 & USA COLD KNIFE STRAIGHT BLADE |
| Generic Name | STRAIGHT BLADE |
| Product Code | EZO |
| Date Received | 2012-04-10 |
| Model Number | K-SB |
| Catalog Number | K-SB |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC. |
| Manufacturer Address | CARRETERA SALTILLO-ZACATECAS KM 4.5 LA ANGOSTURA, C.P. MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-10 |