MAUDE Adverse Event Report: US ENDOSCOPY BIOGUARD; COLONOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	00711780
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/22/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The button was placed on the scope, in the usual fashion, and when the physician pushed the spring-loaded button, it broke apart in pieces.The staff reported several other instances, however it was not brought to management's attention until recently.The staff have determined, based on product packaging, the button was contained within the via procedure kit (#00719709).The department stocks additional buttons, however they come two (blue and red) to a package where this package contains only one (blue) button.The kit is wrapped which prevents visual inspection of its contents, so there is no way to determine which kits have this particular lot number.The staff have been asked to retain the outer package wrap as well to track kit lot numbers too.

• Brand Name: BIOGUARD
• Common Device Name: COLONOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): US ENDOSCOPY; 5976 helsley road; mentor OH 44060
• MDR Report Key: 7411335
• Report Number: 7411335
• Device Sequence Number: 1264069
• Product Code: FDF
• UDI-Device Identifier: 00816765012772
• UDI-Public: (01)00816765012772
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/27/2018
• Report Date (Section F): 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 10/29/2019
• Device Model Number: 00711780
• Device Catalogue Number: 00711780
• Device Lot Number: 1710078
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENDOSCOPY SCOPE
• Date Report Sent to FDA: 03/26/2018