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

Model Number	HP-SG3
Medical Device Problem Code	Charred (1086)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/05/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This investigation is currently ongoing.Any additional information will be provided in the follow-up report.
Event or Problem Description
According to the report, "hp [handpiece] was fired and it would not work.So staff opened another hp and completed the case.".
Additional Manufacturer Narrative
According to the report, "hp [handpiece] was fired and it would not work.So staff opened another hp and completed the case." additional information was requested via email on 04/06/2016.A reply was received on 04/06/2016 stating, "the handpiece tested fine.When he went to do the tmr, it did not fire.The second handpiece was readily available." a sample review was conducted on 04/21/2016.The returned handpiece was visually inspected.The hospital returned handpiece (b)(4); however, the original packaging was not returned.The report stated that the handpiece test fired without an issue but when the surgeon attempted to use it, it would not fire.Upon removing it from the bag, (b)(4) had the multifilament fiber pulled out from the distal end of the coupler.The ends of the multifilament fiber appeared to be charred.The coupler was then opened and it also appeared charred inside.The inside of the coupler had pieces of broken and charred fibers inside of it.It appears as though the multifilament fiber end became dislodged and the handpiece was fired before the multifilament fiber end came completely out of the coupler.The root cause remains unknown; however the issue noted was most likely caused from some kind of mechanical force dislodging the multifilament fibers from the coupler and then attempting to fire it.The manufacturing records for lot ta-04089 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, "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.".
Event or Problem Description
According to the report, "hp [handpiece] was fired and it would not work.So staff opened another hp and completed the case.".

• Brand Name: SOLOGRIP III HANDPIECE
• Common Device Name: TRANSMYOCARDIAL REVASCULARIZATION LASER HANDPIECE
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd., nw; kennesaw GA 30144
• MDR Report Key: 5669580
• Report Number: 1063481-2016-00048
• Device Sequence Number: 16188066
• Product Code: MNO
• UDI-Device Identifier: 00877234000102
• UDI-Public: (01)00877234000102(17)171125(10)TA-04089
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P970029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 11/25/2017
• Device Model Number: HP-SG3
• Device Lot Number: TA-04089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/20/2016
• Supplement Report FDA Received Date: 06/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1