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 2017-02-02 for SOLOGRIP III HANDPIECE HP-SG3 manufactured by Cryolife, Inc..
[66333970]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[66333971]
According to the report, "[the complainant] reported to me that when they plugged in the tmr sologrip handpiece, it did not have any power going through it when they test fired it. They put it aside and used another handpiece which worked fine. She kept the unit in question and will return when we request it. "
Patient Sequence No: 1, Text Type: D, B5
[69223949]
Additional information - sample evaluation one hand piece, lot number ta? 04095, serial number (b)(4), was returned to cryolife. The hospital returned the hand piece in the cryolife-supplied return kit. Upon initial inspection, no damage was noted to the distal tip, handpiece, monofilament and multifilament fiber sheaths, extender nut connector, or exterior of the coupler. The handpiece was connected to the hene laser (model 25-lhr-121-249, serial number (b)(4)) to detect breakage in the monofilament or multifilament fibers. The handpiece did not effectively deliver light energy, indicating a breakage somewhere in the fibers. While it is normal to see a small amount of light energy within the coupler between the monofilament and multifilament fibers, a greater than normal amount of light energy was seen inside the coupler. The handpiece was picked up by a field assurance associate and the multifilament fiber disconnected from the coupler. The coupler was then opened. A small amount of charring was seen within the handpiece and the multifilament fibers were not broken at the same length, indicating the fibers broke while the user was pulling on the handpiece while attempting to fire it. This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[69223950]
According to the report, "[the complainant] reported to me that when they plugged in the tmr sologrip handpiece, it did not have any power going through it when they test fired it. They put it aside and used another handpiece which worked fine. She kept the unit in question and will return when we request it. " surgery was prolonged.
Patient Sequence No: 1, Text Type: D, B5
[70567002]
*additional information - sample evaluation* one hand piece, lot number ta? 04095, serial number (b)(4), was returned to cryolife. The hospital returned the hand piece in the cryolife-supplied return kit. Upon initial inspection, no damage was noted to the distal tip, handpiece, monofilament and multifilament fiber sheaths, extender nut connector, or exterior of the coupler. The handpiece was connected to the hene laser (model 25-lhr-121-249, serial number (b)(4)) to detect breakage in the monofilament or multifilament fibers. The handpiece did not effectively deliver light energy, indicating a breakage somewhere in the fibers. While it is normal to see a small amount of light energy within the coupler between the monofilament and multifilament fibers, a greater than normal amount of light energy was seen inside the coupler. The handpiece was picked up by a field assurance associate and the multifilament fiber disconnected from the coupler. The coupler was then opened. A small amount of charring was seen within the handpiece and the multifilament fibers were not broken at the same length, indicating the fibers broke while the user was pulling on the handpiece while attempting to fire it. The device history record for lot ta-04095 was reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record. Based on the sample evaluation, the damage is consistent with damage caused by a user pulling on the handpiece while attempting to fire it. If the fiber becomes bent or broken and the laser is pulsed, extreme heat is produced resulting in charring of the fibers and subsequent breakage of the fiber bundle. 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
[70567003]
According to the report, "[the complainant] reported to me that when they plugged in the tmr sologrip handpiece, it did not have any power going through it when they test fired it. They put it aside and used another handpiece which worked fine. She kept the unit in question and will return when we request it. " surgery was prolonged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2017-00003 |
| MDR Report Key | 6295924 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-02-02 |
| Date of Report | 2017-03-15 |
| Date of Event | 2016-12-30 |
| Date Facility Aware | 2017-01-03 |
| Date Mfgr Received | 2017-01-03 |
| Date Added to Maude | 2017-02-02 |
| 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. |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal | 30144 |
| Manufacturer G1 | CRYOLIFE, INC. |
| Manufacturer Street | 1655 ROBERTS BLVD. |
| 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 | 2017-02-02 |
| Returned To Mfg | 2017-01-17 |
| Model Number | HP-SG3 |
| Lot Number | TA-04095 |
| 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. KENNESAW GA 30144 US 30144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-02-02 |