MAUDE Adverse Event Report: GALIL MEDICAL LTD. PRESICE CRYOABLATION SYSTEM; CRYOSURGICAL UNIT, ACCESSORIES

Model Number FPRCH2047

Device Problem Material Discolored (1170)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/01/2014

Event Type  malfunction  

Event Description

During a cryoablation procedure, the presice system screen turned pink.The procedure was completed successfully.After the procedure, the screen was tested again (machine was turned off and then on again) and the problem persisted.The field service engineer visited the hospital and changed the vga cable and the machine screen went back to its original color.

Manufacturer Narrative

Following the procedure, a field service engineer visited the hospital and changed out the vga cable.The issue of the pink screen was resolved.If additional information becomes available, a follow-up report will be filed.

• Brand Name: PRESICE CRYOABLATION SYSTEM
• Type of Device: CRYOSURGICAL UNIT, ACCESSORIES
• Manufacturer (Section D): GALIL MEDICAL LTD.; yokneam ; IS
• Manufacturer (Section G): GALIL MEDICAL LTD; 1 tavor building; yokneam 2069 2; IS 20692
• Manufacturer Contact: amy mckinney, sr dir ; 4364 round lake road; arden hills, MN 55112 ; 6512875096
• MDR Report Key: 4307527
• MDR Text Key: 16088687
• Report Number: 9616793-2014-00015
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K060390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/26/2014

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
• Device Operator: Other
• Device Model Number: FPRCH2047
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/26/2014
• Initial Date FDA Received: 11/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1