MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-10-21 for COLD KNIFE, STRAIGHT BLADE, 3/PKG K-SB manufactured by Gyrus Acmi Inc..
[1246097]
Patient underwent a cystoscopy for urethral stricture release. The cold knife was advanced through the cystoscope and when the surgeon tried to use the knife, it broke in the patient's urethra. He tried unsuccessfully for an hour to retrieve the knife under fluoroscopy. The surgeon, upon consulting with the chairman of surgery and another urologist determined it to be in the patient's best interest to leave the blade in the urethra. A foley catheter was inserted into the urethra. The patient was discharged with the blade still inside of his urethra. He was told to consult with his urologist. It is unknown what the urologist's plan of care will be related to the retained foreign body.
Patient Sequence No: 1, Text Type: D, B5
[8291502]
This device is being held by the risk management department of the hospital. The facility sent us a copy of the label and also a picture of the broken device. According to the ifu, the device is single use only, and requires it to be sterilized prior to use. The risk manager stated that she did not have any information regarding the processing of the device prior to use in the case or if it had been reprocessed prior to it's use. Multiple attempts to obtain further information from the hospital have been unsuccessful, and the device has not been returned for evaluation. As a result, a determination cannot be made at this time. If further information becomes available, gyrus acmi will continue the investigation and update the agency accordingly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006159227-2009-00008 |
| MDR Report Key | 1514997 |
| Report Source | 06 |
| Date Received | 2009-10-21 |
| Date of Report | 2009-10-21 |
| Date of Event | 2009-09-25 |
| Date Facility Aware | 2009-09-25 |
| Date Mfgr Received | 2009-09-28 |
| Device Manufacturer Date | 2001-04-01 |
| Date Added to Maude | 2009-11-12 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| 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, 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 | COLD KNIFE, STRAIGHT BLADE, 3/PKG |
| Generic Name | COLD KNIFE, STRAIGHT BLADE, 3/PKG |
| Product Code | GDX |
| Date Received | 2009-10-21 |
| Model Number | K-SB |
| Catalog Number | K-SB |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 8 YR |
| 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. 0000 MX 0000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-10-21 |