MAUDE Adverse Event Report: MEDEON BIODESIGN, INC. CLICKCLEAN; 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
Additional Manufacturer Narrative
We have already sent a paper mdr (form 3500a) to this case and received a mail from fda to inform us the need to submit a reporting case via emdr.On aug.26, 2019.Our report was delayed due to the enrollment process.It is our first electronic report.Signup process needed to be set up.
Event or Problem Description
In one of the clickclean clinical use, the lower part of the screen is blocked and more than 6 clicks cannot clear the view: the blockage happened from the beginning of the case, not during the case.The blockage looked "cloudy" and "blurry" and user can see the objects vaguely, just as see through fog.At the beginning of the 1st clickclean use, the blurry account for 25% of the lower-left corner of the screen.The nurse cleaned the scope by a surgical sponge before inserting the scope to 2nd clickclean.The blockage on the 2nd clickclean is around 10%-15% near the bottom left edge of the screen.The total procedure delay due to clickclean swap is around 3-5min.The user used the 2nd clickclean to throughout the rest of the surgical procedure.The two devices were not able to be returned and not able to verify if the device or scope cause the image blackage.

• Brand Name: CLICKCLEAN
• Common Device Name: LAPAROSCOPE LENS SHIELD DEVICE
• Manufacturer (Section D): MEDEON BIODESIGN, INC.; 7f, 116,hougang st.; taipei, 11170 ; TW 11170
• MDR Report Key: 9149536
• Report Number: 3012452802-2019-00001
• Device Sequence Number: 2782711
• Product Code: GCJ
• UDI-Device Identifier: 04719872920182
• UDI-Public: 04719872920182
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K160172
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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 Expiration Date: 12/10/2019
• Device Model Number: UL330
• Device Catalogue Number: UL330
• Device Lot Number: 18120601
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 10/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1