MAUDE Adverse Event Report: CRYOLIFE, INC. SOLARGEN III HANDPIECE; TRANSMYOCARDIAL REVASCULARIZATION LASER HANDPIECE

Model Number HP-SG3

Device Problem Calibration Error (1078)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2015

Event Type  malfunction  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

According to the report, "circulator was getting the hand piece ready for use yet it was not working properly." the hospital provided information which stated "the laser would not pass the calibration process on four different tries." the procedure was delayed 20 minutes as another handpiece was obtained and used without any further issues.

Manufacturer Narrative

According to the report, "circulator was getting the hand piece ready for use yet it was not working properly." the hospital provided information which stated "the laser would not pass the calibration process on four different tries." the procedure was delayed 20 minutes as another handpiece was obtained and used without any further issues.Additional information indicated "[handpiece ta-04070] did not pass laser output text [test] x4 tries - added approximately 20 mins [minutes] to procedure - nurse had to leave room to get another laser fiber [handpiece]" and "the laser would not pass the calibration process on four different tries." the manufacturing records for lot ta-04070 were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.The lot passed functional testing and met cryolife release specifications.The handpiece was returned and evaluated.No damage was noted.The handpiece was connected to the helium-neon (hene) laser to test functionality and effectively delivered laser.The handpiece was tested at its calibration of 43%, as well as 49% and 50% numerous times and functioned properly.The handpiece was connected to a solargen 2100s console and was tested, delivering laser bursts onto black laser alignment paper.It functioned with no defects noted.A root cause could not be determined and the complaint could not be confirmed as the handpiece effectively delivered laser energy.

Event Description

According to the report, "circulator was getting the hand piece ready for use yet it was not working properly." the hospital provided information which stated "the laser would not pass the calibration process on four different tries." the procedure was delayed 20 minutes as another handpiece was obtained and used without any further issues.

• Brand Name: SOLARGEN III HANDPIECE
• Type of Device: TRANSMYOCARDIAL REVASCULARIZATION LASER HANDPIECE
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd., nw; kennesaw GA 30144
• Manufacturer (Section G): CRYOLIFE, INC.; 1655 roberts blvd., nw; kennesaw GA 30144
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 5093522
• MDR Text Key: 26476874
• Report Number: 1063481-2015-00229
• Device Sequence Number: 1
• Product Code: MNO
• UDI-Device Identifier: 00877234000102
• UDI-Public: 01008772340001021717022110TA04070
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/21/2017
• Device Model Number: HP-SG3
• Device Lot Number: TA-04070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1