MAUDE Adverse Event Report: MEDEON BIODESIGN, INC. CLICKCLEAN 30 DEG; LAPAROSCOPE LENS SHIELD DEVICE

Model Number	UL330
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/23/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During a procedure the doctor attempted to use the clickclean and the lower left part was blocked.She tried to clear it several times and was unsuccessful.The anesthesia time was extended briefly.There was no harm to the patient.

• Brand Name: CLICKCLEAN 30 DEG
• Common Device Name: LAPAROSCOPE LENS SHIELD DEVICE
• Manufacturer (Section D): MEDEON BIODESIGN, INC.; 7f, 116, hougang st,; taipei, 11170 ; TW 11170
• MDR Report Key: 8875104
• Report Number: 1223422-2019-00021
• Device Sequence Number: 16758579
• Product Code: GCJ
• UDI-Device Identifier: 04719872920182
• UDI-Public: 04719872920182
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/08/2019
• Report Date (Section F): 08/08/2019

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: Health Professional
• Device Model Number: UL330
• Device Catalogue Number: UL330
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/25/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/08/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 08/08/2019