MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. ASSURANCE CLIP

Model Number	00711882
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Steris is not the manufacturer of the assurance clip subject of reported event.Steris has notified the manufacturer, ags medtech, of the reported event to internally investigate and evaluate for reportability in accordance with 21 cfr part 803.The device subject of the reported event was returned to the supplier for evaluation.Investigation of this event is still in process, and a follow up will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that during a patient procedure they discovered their assurance clip was bent which did not allow it to perform properly.A new assurance clip was used to complete the procedure successfully, but there was a slight procedure delay as user facility personnel had to switch out the devices.No report of injury.
Additional Manufacturer Narrative
The assurance clip subject of the reported event was returned to ags medtech for evaluation.However, the root cause of the event could not be determined.No additional issues have been reported.

• Brand Name: ASSURANCE CLIP
• Common Device Name: CLIP
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060
• MDR Report Key: 16960658
• Report Number: 1528319-2023-00016
• Device Sequence Number: 5244074
• Product Code: PKL
• UDI-Device Identifier: 00724995190514
• UDI-Public: 00724995190514
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2023

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: 00711882
• Device Catalogue Number: 00711882
• Device Lot Number: 034507
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2023
• Supplement Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown