MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-11-19 for SOLOGRIP III HANDPIECE HP-SG3 manufactured by Cardiogenesis Corporation.
[5003764]
Surgeon completed 19 channels on the patient and then continued to conduct a cabg. Later in the case the surgeon decided to add more channels and it was discovered that the handpiece was not functional and the cable had sepaerated at the coupler. The staff had to open another handpiece to complete the procedure. There was no delay in te surgery and the patient had no impact.
Patient Sequence No: 1, Text Type: D, B5
[12577423]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[24052259]
The surgeon completed 19 channels on the patient of tmr and then continued to conduct a cabg. Later in the case the surgeon decided to add more channels and it was discovered that the handpiece was not functional and the cable had separated at the coupler. The staff opened another handpiece to complete the procedure. There was no delay in the surgery and the patient had no impact. The handpiece was returned to cryolife on 11/12/2014. The handpiece was visually inspected. The handpiece was returned to cryolife in two pieces with the disconnection being on the monofilament side of the coupler. The monofilament fiber was not disconnected from the coupler. Charring could be seen where the fiber became disconnected and the plastic outer covering had been melted. Damage noted during the review is consistent with damage caused by firing the laser while the monofilament fiber is damaged. If the fiber becomes bent or damaged and the laser is pulsed extreme heat is produced resulting in charring of the fiber which can eventually burn through the monofilament fiber. The manufacturing records for the lot number was reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record. The ifu states "if breaks or fractures appear in the optical fiber, immediately discontinue use and replace with a new handpiece. " all units from the lot were constructed from approved components and met all specifications; there is no indication that an error or deficiency occurred at cryolife. The ifu contains adequate instructions and warnings for proper operation of the device.
Patient Sequence No: 1, Text Type: N, H10
[24052260]
Surgeon completed 19 channels on the patient and then continued to conduct a cabg. Later in the case the surgeon decided to add more channels and it was discovered that the handpiece was not functional and the cable had separated at the coupler. The staff had to open another handpiece to complete the procedure. There was no delay in te surgery and the patient had no impact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2950727-2014-00025 |
| MDR Report Key | 4262851 |
| Report Source | 05,07 |
| Date Received | 2014-11-19 |
| Date of Report | 2014-11-10 |
| Date of Event | 2014-11-10 |
| Date Mfgr Received | 2014-11-10 |
| Date Added to Maude | 2014-11-20 |
| 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 | 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 | CARDIOGENESIS CORPORATION |
| 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 | SOLOGRIP III HANDPIECE |
| Generic Name | TRANSMYOCARDIAL REVASCULARIZATION |
| Product Code | MNO |
| Date Received | 2014-11-19 |
| Returned To Mfg | 2014-11-12 |
| Model Number | HP-SG3 |
| Lot Number | TA-04039 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDIOGENESIS CORPORATION |
| Manufacturer Address | 1655 ROBERTS BLVD., NW KENNESAW GA 30144 US 30144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-11-19 |