MAUDE Adverse Event Report: US ENDOSCOPY ASCENDO; LIFTING AGENT

Model Number	00712934
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that a patient received a "burn" on their ascending colon after being injected with ascendo submucosal lifting agent.It is unknown if additional medical treatment was administered.
Additional Manufacturer Narrative
The device subject of the reported event was returned for evaluation and no abnormalities were noted.A root cause of the reported event could not be determined; however, was most likely the result of an allergic reaction with the patient.The ifu for the ascendo submucosal lifting agent states, "during the procedure do not exceed a total dose of 50ml per patient, either in single or in multiple administrations.Do not use this medical device with disinfectants containing quaternary ammonium salts (e.G.Benzalkonium chloride).This may cause precipitate.Do not reuse the ascendo submucosal lifting agent.It can cause side effects like inflammation, infection, etc.The ascendo submucosal lifting agent is intended for use in the gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers, or other gastrointestinal mucosal lesions prior to excision with a snare or endoscopic device." a 3-year complaint review was conducted and confirmed this to be an isolated event.No additional issues have been reported.

• Brand Name: ASCENDO
• Common Device Name: LIFTING AGENT
• 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: 20820222
• Report Number: 1528319-2024-00105
• Device Sequence Number: 18051575
• Product Code: PLL
• UDI-Device Identifier: 00724995221614
• UDI-Public: (01)00724995221614(11)240611(17)260610(10)LM06202
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K220434
• 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
• Report Date (Section B): 11/27/2024

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 Expiration Date: 06/10/2026
• Device Model Number: 00712934
• Device Catalogue Number: 00712934
• Device Lot Number: (10)LM06202
• 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: 10/30/2024
• Initial Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2024
• 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