MAUDE Adverse Event Report: LIEBEL-FLARSHEIM HUT EXT DR FINAL ASSY,ST,FPD

Model Number 414008

Device Problem No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2019

Event Type  malfunction  

Event Description

This incident was reported on (b)(6) 2019, as customer had an issue where, toward the end of the case, they were not able to get a fluoro image all they would see was a grey image.Customer also stated that study was not completed, patient was removed from anesthesia and transferred to another facility for treatment.No harm to patient was reported for this incident.

Event Description

This incident was reported on 21 may 2019, as customer had an issue where, toward the end of the case, they were not able to get a fluoro image all they would see was a grey image.Customer also stated that study was not completed, patient was removed from anesthesia and transferred to another facility for treatment.No harm to patient was reported for this incident.

Manufacturer Narrative

Overall investigation summary: a customer reported to canon service that, after a procedure, they were not able to produce fluoro images on their hyrdavision urology system.All the images appeared gray.As a result, the next scheduled procedure was shifted to another urology suit.Canon sent their field service engineer (fse) on-site to investigate.Upon arrival, the fse found the system to be fully functional.The fse was unable to duplicate the issue, or confirm the complaint.Therefore, the fse downloaded the system's event logs and forwarded these to varex , the manufacturer of the imaging system, for review and analysis.Varex analyzed the system's event logs and determined that the system was producing fluoro, however, the image intensity was set too high for the images to be visible by the user.When the system is in automatic exposure mode, the system automatically adjusts the intensity based on patient density.Therefore, the only way an over-exposure fluoroscopy could occur on a fully functional system is for the operator to have placed the system in the manual exposure mode, and adjust the intensity manually.Any failure of the auto brightness control mechanism would require a system repair, by the fse.A review of cts shows no similar issues reported on this unit.Root / probable cause code: unknown.Root / probable cause summary: refer to investigation summary.Based on the information provided, this appears to be an operator issue.No further investigation needed at this time.Qa will continue to monitor and trend for similar issues.No capa at this time, these trends and issues are reported on during quality metrics review and during the management review meetings to consider input for corrective action.Disposition summary: unit returned to service.

• Brand Name: HUT EXT DR FINAL ASSY,ST,FPD
• Type of Device: HUT EXT DR FINAL ASSY,ST,FPD
• Manufacturer (Section D): LIEBEL-FLARSHEIM; 2111 e galbraith road; cincinnati OH 45237
• MDR Report Key: 8711796
• MDR Text Key: 148826263
• Report Number: 1518293-2019-00013
• Device Sequence Number: 1
• Product Code: MQB
• Combination Product (y/n): N
• PMA/PMN Number: K121838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 414008
• Date Manufacturer Received: 05/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1