MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2014-09-22 for PEARL 5.0 HANDPIECE HP-PRL5 manufactured by Cardiogenesis Corporation.
[15323833]
According to the report, the surgeon completed a robotic tmr procedure where two pearl 5. 0 handpieces broke. After approximately 12 channels, the fiber broke on the tip of the first handpiece. There was a slight delay in procedure while a second handpiece was opened for use. After approximately 25 channels, the tip broke on the second handpiece. A total of 37 channels were placed. This report represents the second handpiece.
Patient Sequence No: 1, Text Type: D, B5
[15550678]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[19801879]
According to the report, the surgeon completed a robotic tmr procedure where two pearl 5. 0 handpieces broke. After approximately 12 channels, the fiber broke on the tip of the first handpiece. There was a slight delay in procedure while a second handpiece was opened for use. After approximately 25 channels, the tip broke on the second handpiece. A total of 37 channels were placed. This report represents the second handpiece.
Patient Sequence No: 1, Text Type: D, B5
[19980731]
According to the report, the surgeon completed a robotic tmr procedure where two pearl 5. 0 handpieces broke. After approximately 12 channels, the fiber broke on the tip of the first handpiece. There was a slight delay in procedure while a second handpiece was opened for use. After approximately 25 channels, the tip broke on the second handpiece. A total of 37 channels were placed. This report represents the second handpiece. The handpiece was returned for evaluation. The observed damage is indicative of user mishandling. Handpiece ta-04009-04 had multifilament fibers that had broken and melted through the plastic. This damage is consistent with damage seen by bending the shaft too sharply. When the laser is pulsed, extreme heat is produced resulting in breakage of the fiber bundle if there is a sharp bend in the fiber. A record review was performed for the lot. The lot was constructed from approved components and met all specifications. The root cause was determined to be user error. The ifu states "excessive stress or tension on the optical fiber contained in the handpiece may result in device damage or malfunction. Do not grip the optical fiber during testing or operation. Do not bend the optical fiber at sharp angles. If breaks or fractures appear in the optical fiber, immediately discontinue use and replace with a new handpiece. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2950727-2014-00022 |
| MDR Report Key | 4105210 |
| Report Source | 05,06,07 |
| Date Received | 2014-09-22 |
| Date of Report | 2014-09-19 |
| Date of Event | 2014-09-19 |
| Date Mfgr Received | 2014-09-19 |
| Date Added to Maude | 2014-10-01 |
| 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 | PEARL 5.0 HANDPIECE |
| Generic Name | TRANSMYOCARDIAL REVASCULARIZATION LASER HANDPIECE |
| Product Code | MNO |
| Date Received | 2014-09-22 |
| Model Number | HP-PRL5 |
| Lot Number | TA-04009 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| 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 | 2014-09-22 |