MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-04-14 for SOLOGRIP III HANDPIECE HP-SG3 manufactured by Cryolife, Inc..
[42753928]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[42753929]
According to the report, "[surgeon] was performing a stand alone tmr on (b)(6) 2016. Sologrip iii handpiece tip was frayed, handpiece would not work. Staff opened up another sologrip iii handpiece and [surgeon] continued the tmr without incident. "
Patient Sequence No: 1, Text Type: D, B5
[47647495]
According to the report, "[surgeon] was performing a stand alone tmr on (b)(6) 2016. Sologrip iii handpiece tip was frayed, handpiece would not work. Staff opened up another sologrip iii handpiece and [surgeon] continued the tmr without incident. " a sample review was conducted on (b)(6) 2016. The returned handpiece was visually inspected. The hospital returned handpiece ta-04043-68; however, the original packaging was not returned. The optical multi-filament fiber portion on the distal end was discolored and appeared frayed. The polypropylene outer covering was not fully encapsulating the optical multi-filament and looked as though it had been melted or burned back. Other than this observation, no other evidence of damage or defects could be noted on the handpiece. When the multi-filament fiber was retracted there was not any portion of it visible, indicating that a portion was missing. The end of the optical multi-filament fiber appeared charred as though it may have been fired. There was debris noted on the inside of the silicone stabilizing cup on the distal end of the handpiece. The guideshaft was cut open at the distal end and examined. It was not possible to determine if there was any charring present due to the diameter of the guideshaft. It looked like the laser had been test fired against a metal object or that it had been fired before the optical multi-filament fiber was fully extended. A test was done on an additional handpiece trying to re-create the damage noted on ta-04043-68. The laser was fired inside a metal basin against the metal without fully extending the fiber (the bowl had water in it but the distal tip was not submerged in the water). The result was the optical multi-filament became charred and there was debris noted inside the silicone stabilizing cup similar to the damage noted on the returned handpiece. The root cause cannot be determined, however, the damage noted is consistent with damage that would occur if the laser was test fired against a metal object and or fired before the optical multi-filament fiber was fully extended. On (b)(6) 2016 an email was sent seeking additional information relating to when the operating room staff noticed the frayed tip and if they tried to use it. An email response was received on (b)(6) 2016 stating, "the surgeon did try to use the handpiece with the frayed tip. It was when he was using it that he noticed the frayed tip. There was no impact to the patient, we used a different handpiece. " the manufacturing records for lot ta-04043 were 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, "fill a small non-metallic water basin with water approximately half full. Note: usage of too little water or a metal basin could result in damage to the test fiber or injury to the user. Ensure the optical fiber is in contact with the surface of the water/saline to protect the fiber while testing. Ensure the optical fiber does not come into contact with the walls of the container. "
Patient Sequence No: 1, Text Type: N, H10
[47647497]
According to the report, "[surgeon] was performing a stand alone tmr on (b)(6) 2016. Sologrip iii handpiece tip was frayed, handpiece would not work. Staff opened up another sologrip iii handpiece and [surgeon] continued the tmr without incident. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2016-00041 |
| MDR Report Key | 5576463 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-04-14 |
| Date of Report | 2016-06-16 |
| Date of Event | 2016-03-11 |
| Date Mfgr Received | 2016-03-17 |
| Date Added to Maude | 2016-04-14 |
| 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 | 2016-04-14 |
| Returned To Mfg | 2016-03-28 |
| Model Number | HP-SG3 |
| Lot Number | TA-04043 |
| Device Expiration Date | 2016-05-31 |
| 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 | 1. Other | 2016-04-14 |