MAUDE Adverse Event Report: GALIL MEDICAL LTD VISUAL-ICE® CRYOABLATION SYSTEM; CRYOSURGICAL DEVICES AND ACCESSORIES,

Model Number FPRCH6000

Device Problems Display or Visual Feedback Problem (1184); Device Displays Incorrect Message (2591); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2018

Event Type  malfunction  

Manufacturer Narrative

The galil field safety engineer in europe discussed the problem with the distributor.Found that the supply line had been dropped and the o-ring that is part of the gas adapter fitting became lost.A replacement part corrected the problem and system performed as expected.

Event Description

The customer reported that the cryoablation procedure was aborted as they lost the o-rings on both vi argon and helium lines.There were no patient consequences reported.

• Brand Name: VISUAL-ICE® CRYOABLATION SYSTEM
• Type of Device: CRYOSURGICAL DEVICES AND ACCESSORIES,
• Manufacturer (Section D): GALIL MEDICAL LTD; 4364 round lake road; arden hills MN 55112
• Manufacturer (Section G): GALIL MEDICAL LTD.; 4364 round lake road w; arden hills MN 55112
• Manufacturer Contact: sandara bausback-aballo ; 300 conshohocken state rd,; 300 four falls corporate ctr.; west conshohocken, PA 19428-2998 ; 6103311537
• MDR Report Key: 7844893
• MDR Text Key: 119152799
• Report Number: 3004462490-2018-00002
• Device Sequence Number: 1
• Product Code: GEH
• UDI-Device Identifier: 00867379000006
• UDI-Public: 0867379000006
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K113860
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FPRCH6000
• Device Catalogue Number: FPRCH6000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1