MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. BIOGUARD AIR/WATER AND SUCTION VALVES

Model Number	00711780
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the customer complaint and the medwatch identified an inconsistent description of the product and event.The user facility has been contacted for clarification and a follow-up report will be sent.
Event or Problem Description
Reference medwatch (b)(4).
Additional Manufacturer Narrative
The user facility initially reported to us endoscopy a single instance of suction valve breakage; however, the medwatch report described additional instances of valve breakage and reported a single instance of a missing valve component.Us endoscopy contacted the user facility to confirm there was no patient or user harm associated with the reports and confirmed the devices subject of these reports had been discarded.On may 15, 2018, a us endoscopy clinical specialist provided in-service training to the user facility gi staff.During in-service, the staff clarified breakage problems were primarily associated with the air/water valve, contrary to the complaint report which had identified the suction valve.The clinical specialist observed incorrect practice by some staff members when inserting the air/water valve into the air/water cylinder on the endoscope.Specifically, some staff members were twisting and forcing the air/water valve during insertion, attempting to orient the valve to a locking feature within the air/water cylinder.This technique is incorrect, as the air/water cylinder does not have a locking feature.The clinical specialist corrected the insertion technique with reference to the bioguard instructions for use.A review of the manufacturing records for bioguard lot #1710078 identified 8,400 bioguard units were manufactured in october 2017.Us endoscopy has confirmed all operations and inspections relating to lot #1710078 were completed according to specification; no anomalies with the subject lot were noted.A review of complaint history for the subject device and lot number confirmed the subject event is the only complaint us endoscopy has received pertaining to this lot.Specific to the product packaging concerns, us endoscopy learned the packaging problem involved a single package which was missing a suction valve.The subject device was not returned for investigation.The date of occurrence and the lot number were unknown.Based on us endoscopy's investigation into the reported events and clinical practices observed, it appears the broken component was the result of improper insertion of the air/water valve into the air/water cylinder on the endoscope.Since in-service activities were completed, no additional issues have been reported.
Event or Problem Description
Reference medwatch 4900220000-2018-8007.

• Brand Name: BIOGUARD AIR/WATER AND SUCTION VALVES
• Common Device Name: AIR/WATER AND SUCTION VALVES
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 7466216
• Report Number: 1528319-2018-00010
• Device Sequence Number: 18858674
• Product Code: ODC
• UDI-Device Identifier: 00816765012772
• UDI-Public: (01)00816765012772
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K151345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/29/2019
• Device Model Number: 00711780
• Device Catalogue Number: 00711780
• Device Lot Number: 1710078
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/29/2018
• Supplement Date Received by Manufacturer: 03/29/2018
• Initial Report FDA Received Date: 04/26/2018
• Supplement Report FDA Received Date: 05/25/2018
• Patient Sequence Number: 1