MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-06-09 for SOLARGEN 2100S CONSOLE SG-2100S manufactured by Cryolife, Inc..
[5912101]
According to the report from the field technician, "laser did not recognize foot pedal. Customer was able to jiggle wire and have laser recognize the foot pedal. " additional information indicated that it was not being used during a procedure at the time of the incident.
Patient Sequence No: 1, Text Type: D, B5
[13506578]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[39800031]
According to the report from the field technician, "laser did not recognize foot pedal. Customer was able to jiggle wire and have laser recognize the foot pedal. " additional information indicated that it was not being used during a procedure at the time of the incident. A sample evaluation was held on 06/25/2015. The solargen console footswitch ((b)(4), lot vss01), power cord, and power cord connector were visually inspected. Footswitch functionality was tested by connecting it to a test console. No external visible damage was noted on the foot switch, power cord, or the power cord connector. Initially, the test console was able to recognize the foot switch when connected. The foot switch was able to engage and control the test fiber. The power cord was then manually manipulated at the point of contact with the foot switch, but this did not affect its ability to function. However, when the power cord was manipulated at the insertion point on the console, the console read "foot switch not installed. " additional information was received from the technicians on 06/26/2015. They inspected the foot pedal further and disassembled the connector that plugs into the laser, finding that the integrity of the foot pedal grounding had been compromised. This would cause the intermittent functioning of the console when connected to the foot switch. The solargen console and its associated footswitch are mobile rental units with a high frequency of use. It is likely that because of the repeated use, plugging and unplugging of the footswitch connector, damage was incurred. Manufacturing and quality data is unavailable for the foot switch shipped as a component of solargen console (b)(4) lot vss01. The device history record of lot vss01, provided by new star lasers does not include the lot number of the footswitch included in the shipment and testing of the footswitch cannot be confirmed. Additionally, functional testing of the console at cryolife with the included components had not yet been implemented as a part of the incoming inspection of laser consoles. The technicians inspected the returned foot pedal and it was discovered that the integrity of the foot pedal connector had been compromised with a broken ground wire. This would cause the intermittent functioning of the console when connected to the laser. An active review of the service history starting on (b)(6) 2012 thru (b)(6) 2015 showed no previous issues or complaints in regards to the foot pedal and the observed error code, "foot switch not installed. " the grounding integrity of the laser foot pedal was compromised by a broken wire in the locking connector that attaches to the back panel on the laser, labeled for the foot pedal. A replacement foot pedal sp2227 was shipped to the customer.
Patient Sequence No: 1, Text Type: N, H10
[39800032]
According to the report from the field technician, "laser did not recognize foot pedal. Customer was able to jiggle wire and have laser recognize the foot pedal. " additional information indicated that it was not being used during a procedure at the time of the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2015-00094 |
| MDR Report Key | 4826405 |
| Report Source | 07 |
| Date Received | 2015-06-09 |
| Date of Report | 2015-06-05 |
| Date of Event | 2015-06-04 |
| Date Added to Maude | 2015-07-07 |
| 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 | HOSPITAL SERVICE TECHNICIAN |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SANDRA O'REILLY |
| Manufacturer Street | 1655 ROBERTS BLVD., NW |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal | 30144 |
| Manufacturer Phone | 7704193355 |
| Manufacturer G1 | CRYOLIFE, INC. |
| Manufacturer Street | 1655 ROBERTS BLVD., NW |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30144 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOLARGEN 2100S CONSOLE |
| Generic Name | TRANSMYOCARDIAL REVASCULARIZATION LASER CONSOLE |
| Product Code | MNO |
| Date Received | 2015-06-09 |
| Returned To Mfg | 2015-06-24 |
| Model Number | SG-2100S |
| Lot Number | VSS01 |
| Operator | HOSPITAL SERVICE TECHNICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRYOLIFE, INC. |
| Manufacturer Address | 1655 ROBERTS BLVD., NW KENNESAW GA 30144 US 30144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-09 |