MAUDE Adverse Event Report: AMBU A/S ASCOPE¿ GASTRO; ASCOPE GASTRO (US VERSION)

Catalog Number	483001000US
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation code: c1901: unable to exclude device problem.We are unable to verify the reported failure (leaking) as complaint sample was not returned for investigation.Based on investigation result, the cause of the reported failure (leaking) could be due to the tubing connection used with the scope was not properly secure which may cause water exit from the distal tip when activating irrigation during the procedure.Ambu production and qc had performed 100% checked on insufflation/rinsing valve on each of the scope.In addition, ambu production performed 100% leak and flow inspection on each of the scope to ensure the product is in good condition prior to shipment.Production, quality control and technical team have been alerted on this market complaint.
Event or Problem Description
The ambu system has been leaking.The patient aspirated and the physician doesn't want to use it anymore.Patient condition was not affected, and is fine no patient harm at time of incident or residually afterwards.Following additional information received: was the endoscope inspected for leaks or water dripping prior to insertion? if so, what was observed? there was not any pre-inspection of leaks or dripping prior to insertion.It was described that water was flowing out like a powerful stream during procedure and continued upon extubation.After procedure, not apparent leaks were observed.Fluid was exiting through the forward water jet channel.Was any intervention required because of the leak (e.G.Suction), or did the patient clear the airway spontaneously by coughing? no serious intervention required.Just suctioning the airway from anesthesia.Airway was cleared.

• Brand Name: ASCOPE¿ GASTRO
• Common Device Name: ASCOPE GASTRO (US VERSION)
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, 2750 ; DA 2750
• Manufacturer (Section G): AMBU SDN. BHD.; lot 69-b, lintang; bayan lepas 6, phase iv; penang, mys 1900, ; MY 1900,
• Manufacturer Contact: catharina engelhardt ; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 25296331
• Report Number: 9610691-2026-00015
• Device Sequence Number: 18453876
• Product Code: FDS
• UDI-Device Identifier: 05707480148172
• UDI-Public: 05707480148172
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K212382
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/27/2026

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 Catalogue Number: 483001000US
• Device Lot Number: 1001246413
• 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: 04/28/2026
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown