MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2015-09-22 for SOLARGEN III HANDPIECE HP-SG3 manufactured by Cryolife, Inc..
[26476874]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[26476875]
According to the report, "circulator was getting the hand piece ready for use yet it was not working properly. " the hospital provided information which stated "the laser would not pass the calibration process on four different tries. " the procedure was delayed 20 minutes as another handpiece was obtained and used without any further issues.
Patient Sequence No: 1, Text Type: D, B5
[34559374]
According to the report, "circulator was getting the hand piece ready for use yet it was not working properly. " the hospital provided information which stated "the laser would not pass the calibration process on four different tries. " the procedure was delayed 20 minutes as another handpiece was obtained and used without any further issues. Additional information indicated "[handpiece ta-04070] did not pass laser output text [test] x4 tries - added approximately 20 mins [minutes] to procedure - nurse had to leave room to get another laser fiber [handpiece]" and "the laser would not pass the calibration process on four different tries. " the manufacturing records for lot ta-04070 were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record. The lot passed functional testing and met cryolife release specifications. The handpiece was returned and evaluated. No damage was noted. The handpiece was connected to the helium-neon (hene) laser to test functionality and effectively delivered laser. The handpiece was tested at its calibration of 43%, as well as 49% and 50% numerous times and functioned properly. The handpiece was connected to a solargen 2100s console and was tested, delivering laser bursts onto black laser alignment paper. It functioned with no defects noted. A root cause could not be determined and the complaint could not be confirmed as the handpiece effectively delivered laser energy.
Patient Sequence No: 1, Text Type: N, H10
[34559375]
According to the report, "circulator was getting the hand piece ready for use yet it was not working properly. " the hospital provided information which stated "the laser would not pass the calibration process on four different tries. " the procedure was delayed 20 minutes as another handpiece was obtained and used without any further issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2015-00229 |
| MDR Report Key | 5093522 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2015-09-22 |
| Date of Report | 2015-08-25 |
| Date of Event | 2015-08-25 |
| Date Mfgr Received | 2015-08-25 |
| Date Added to Maude | 2015-09-22 |
| 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 | ROCHELLE MANEY |
| 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 III HANDPIECE |
| Generic Name | TRANSMYOCARDIAL REVASCULARIZATION LASER HANDPIECE |
| Product Code | MNO |
| Date Received | 2015-09-22 |
| Returned To Mfg | 2015-08-31 |
| Model Number | HP-SG3 |
| Lot Number | TA-04070 |
| Device Expiration Date | 2017-02-21 |
| Operator | PHYSICIAN |
| 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 | 2015-09-22 |