MAUDE Adverse Event Report: Erbe Medical. LLC ERBEFLO CleverCap® Hybrid CO2 Tubing/Cap Sets

Catalog Number	20325-239
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that hybrid co2 tubing/cap sets for olympus® scopes & co2 leaked at the distal end prior to endoscopic procedures.No other information was provided regarding any other accessory used in the procedure.Specifically, it was reported that there was an unintended flow at the distal end of scopes prior to inserting a scope into a patient.There was no report of any patient injury.
Additional Manufacturer Narrative
Sets are in the process of being returned to erbe usa and will be forwarded to the manufacturer for further inspection/testing as needed.Nevertheless, we received similar reports of sets leaking at the distal end of the irrigation line and down scopes.At this time, two (2) primary causes of the issue have been determined: off-label use in that erbe medical llc sets are being used with other manufacturers port connectors (note: per the notes on use for the set's, only erbe accessories (i.E., erbe port connectors), etc.Are to be used with erbe tubing/cap sets.A change had been made to the set's connector.Currently sets are now being produced with the previous connector to minimize/eliminate leaking.Other contributing causes of leaking at the end of scopes are also being investigated.If the evaluation findings are different than what has already been reported and/or any other prominent causes are determined and/or remedies are implemented to resolve leaking, a follow-up mdr will be filed.

• Brand Name: ERBEFLO CleverCap® Hybrid CO2 Tubing/Cap Sets
• Common Device Name: CO2 Tubing/Cap Sets
• Manufacturer (Section D): Erbe Medical. LLC; 405 w geneva drive; tempe AZ 85282
• Manufacturer (Section G): Erbe Medical, LLC; 405 w geneva drive; tempe AZ 85282
• Manufacturer Contact: john tartal ; 2225 northwest parkway; marietta, GA 30067--876 ; +1(770)955-4400
• MDR Report Key: 50688526
• Report Number: 3020712480-2026-00036
• Device Sequence Number: 5166824
• Product Code: FEQ
• UDI-Device Identifier: 04065655000375
• UDI-Public: 04065655000375
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K162152
• 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: Administrator/Supervisor
• Remedial Action: Notification,Recall
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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 Catalogue Number: 20325-239
• Device Lot Number: WO473987
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2025
• 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: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3020712480-03312026-R-00
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Unknown
• Patient Weight: 150 LB