MAUDE Adverse Event Report: US ENDOSCOPY ASSURANCE; ASSURANCE CLIP

Model Number	00711885
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Steris has notified the supplier, (b)(4), of the reported event.The device subject of the reported event was not returned for evaluation.Without the return of the device, a root cause could not be determined.Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that during a patient procedure two assurance clips fell off the device into the patient.The clips had to be retrieved using a net.The procedure was completed successfully using another assurance clip.No report of injury.
Additional Manufacturer Narrative
The supplier reported that the assurance clip may have not stayed on the mucosa due to too much tissue being grabbed.Steris offered in-service training on the proper use and operation of the assurance clip; however, the user facility declined.The dhr for the lot subject of the event was reviewed and confirmed the device was manufactured to specifications; no abnormalities were noted.A 2-year complaint review was conducted and confirmed this to be an isolated event.No additional issues have been reported.

• Brand Name: ASSURANCE
• Common Device Name: ASSURANCE CLIP
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor OH
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4404130648
• MDR Report Key: 20368173
• Report Number: 1528319-2024-00082
• Device Sequence Number: 15170688
• Product Code: PKL
• UDI-Device Identifier: 00724995219154
• UDI-Public: (01)00724995219154(11)231202(17)261201(10)074809
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K172727
• 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): 10/04/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: 00711885
• Device Catalogue Number: 00711885
• Device Lot Number: (10)074809
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2023
• 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