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 2017-10-27 for SOLOGRIP III HANDPIECE HP-SG3 manufactured by Cryolife, Inc..
[91093803]
A sample evaluation was performed for the returned hand piece, lot number ta? 04102, serial (b)(4). It was noted the thumb slide on the hand piece seemed to be catching on something internal, requiring more pressure to advance the fiber. The hand piece was taken apart to look internally. It was noted that everything looked to be assembled properly. After further examination, it was noted that the there is a misalignment between the fiber support stainless steel cube and the white pebax sleeve, creating resistance when advanced. The tubing looks to be cut at an angle rather than square. The manufacturing records for the hp-sg3, ta-04102-82, were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record. All lots passed functional testing and met release specifications. During the investigation no non-conformances or deviations were noted. This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[91093804]
Per the notification sent by the rep "hp [hand piece] was used and surgeon complained that the thumb lever was very stiff and hard to advance. Hp was used on the case and there was no impact to the patient. Hp fiber was cut at the end of the case after use.. It was tangled in some of the equipment on the surgical field. No other information provided. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2017-00037 |
| MDR Report Key | 6984124 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-10-27 |
| Date of Report | 2018-04-03 |
| Date of Event | 2017-10-02 |
| Date Facility Aware | 2017-10-02 |
| Date Mfgr Received | 2017-10-02 |
| Date Added to Maude | 2017-10-27 |
| 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 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 | SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION |
| Product Code | MNO |
| Date Received | 2017-10-27 |
| Returned To Mfg | 2017-10-12 |
| Model Number | HP-SG3 |
| Catalog Number | HP-SG3 |
| Lot Number | TA-04102 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-10-27 |