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 2016-02-01 for SOLOGRIP III HANDPIECE HP-SG3 manufactured by Cryolife, Inc..
[37186183]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[37186184]
According to the report, "#1 - laser fiber was seperated from center connection. "
Patient Sequence No: 1, Text Type: D, B5
[41148325]
According to the report, "#1 - laser fiber was separated from center connection. " an email was sent asking if the handpiece had been used, if tmr had been performed, and if there was any impact to the patient. A response was received stating that the staff had the issue with the handpiece during set up for the laser portion of the case, causing a delay. Another handpiece was opened and worked properly. A sample review was conducted and the returned handpiece was visually inspected. Ta-04049-35 had the single fiber pulled out from the coupler. It appeared as though the cladding had not been removed to a sufficient point in order for the single fiber to seat into the adhesive inside the coupler. The adhesive was present inside the coupler and a dark mark (burn mark) was visible on the single fiber. The thumb slide mechanism on the handpiece was functional and the fibers retracted without a problem. Further evaluation was performed and measurements were taken using calipers to determine if the cladding had been removed to a sufficient point in order for the single fiber to seat into the adhesive inside the coupler. These measurements met release specifications. The manufacturing records for lot ta-04049-35 was reviewed, and it was confirmed that all records were controlled, available for review, and met all release specifications per the device master record. The root cause could not be determined. The ifu provides the following instructions, "each sologrip iii handpiece is a fragile surgical instrument. Use caution when removing contents from packaging and during use. Excessive stress or tension on the optical fiber contained in the handpiece may result in device damage or malfunction. Always place the laser console near the sterile field. Position the white fiber coupler near the operative site to minimize tension on the fiber when the handpiece is in use. "
Patient Sequence No: 1, Text Type: N, H10
[41148326]
According to the report, "#1 - laser fiber was seperated from center connection. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2016-00008 |
| MDR Report Key | 5401177 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2016-02-01 |
| Date of Report | 2015-12-29 |
| Date of Event | 2015-12-29 |
| Date Mfgr Received | 2015-12-29 |
| Date Added to Maude | 2016-02-01 |
| 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 | 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 | SOLOGRIP III HANDPIECE |
| Generic Name | TRANSMYOCARDIAL REVASCULARIZATION LASER HANDPIECE |
| Product Code | MNO |
| Date Received | 2016-02-01 |
| Returned To Mfg | 2016-01-13 |
| Model Number | HP-SG3 |
| Lot Number | TA-04049 |
| Device Expiration Date | 2016-08-23 |
| 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 | 2016-02-01 |