PEARL 5.0 HANDPIECE HP-PRL5

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2014-09-22 for PEARL 5.0 HANDPIECE HP-PRL5 manufactured by Cardiogenesis Corporation.

Event Text Entries

[15323833] According to the report, the surgeon completed a robotic tmr procedure where two pearl 5. 0 handpieces broke. After approximately 12 channels, the fiber broke on the tip of the first handpiece. There was a slight delay in procedure while a second handpiece was opened for use. After approximately 25 channels, the tip broke on the second handpiece. A total of 37 channels were placed. This report represents the second handpiece.
Patient Sequence No: 1, Text Type: D, B5


[15550678] This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10


[19801879] According to the report, the surgeon completed a robotic tmr procedure where two pearl 5. 0 handpieces broke. After approximately 12 channels, the fiber broke on the tip of the first handpiece. There was a slight delay in procedure while a second handpiece was opened for use. After approximately 25 channels, the tip broke on the second handpiece. A total of 37 channels were placed. This report represents the second handpiece.
Patient Sequence No: 1, Text Type: D, B5


[19980731] According to the report, the surgeon completed a robotic tmr procedure where two pearl 5. 0 handpieces broke. After approximately 12 channels, the fiber broke on the tip of the first handpiece. There was a slight delay in procedure while a second handpiece was opened for use. After approximately 25 channels, the tip broke on the second handpiece. A total of 37 channels were placed. This report represents the second handpiece. The handpiece was returned for evaluation. The observed damage is indicative of user mishandling. Handpiece ta-04009-04 had multifilament fibers that had broken and melted through the plastic. This damage is consistent with damage seen by bending the shaft too sharply. When the laser is pulsed, extreme heat is produced resulting in breakage of the fiber bundle if there is a sharp bend in the fiber. A record review was performed for the lot. The lot was constructed from approved components and met all specifications. The root cause was determined to be user error. The ifu states "excessive stress or tension on the optical fiber contained in the handpiece may result in device damage or malfunction. Do not grip the optical fiber during testing or operation. Do not bend the optical fiber at sharp angles. If breaks or fractures appear in the optical fiber, immediately discontinue use and replace with a new handpiece. "
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2950727-2014-00022
MDR Report Key4105210
Report Source05,06,07
Date Received2014-09-22
Date of Report2014-09-19
Date of Event2014-09-19
Date Mfgr Received2014-09-19
Date Added to Maude2014-10-01
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactSANDRA O'REILLY
Manufacturer Street1655 ROBERTS BLVD., NW
Manufacturer CityKENNESAW GA 30144
Manufacturer CountryUS
Manufacturer Postal30144
Manufacturer Phone7704193355
Manufacturer G1CARDIOGENESIS CORPORATION
Manufacturer Street1655 ROBERTS BLVD., NW
Manufacturer CityKENNESAW GA 30144
Manufacturer CountryUS
Manufacturer Postal Code30144
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePEARL 5.0 HANDPIECE
Generic NameTRANSMYOCARDIAL REVASCULARIZATION LASER HANDPIECE
Product CodeMNO
Date Received2014-09-22
Model NumberHP-PRL5
Lot NumberTA-04009
OperatorPHYSICIAN
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCARDIOGENESIS CORPORATION
Manufacturer Address1655 ROBERTS BLVD., NW KENNESAW GA 30144 US 30144


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2014-09-22

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