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	04/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A set was returned to erbe usa and 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: 1.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.2.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.
Event or Problem Description
It was reported that the hybrid co2 tubing/cap set for olympus® scopes & co2 was involved in an incident during an esophagogastroduodenoscopy (egd).The set was used with a co2 insufflator [model eco 2 plus, part number (p/n) 2n100-068, serial number (s/n) (b)(6)], irrigation pump (model eip 2, p/n 103250-000, s/n (b)(6), and a port connector (p/n 20325-211).Specifically, when insufflating the stomach with co2, water sprayed from the distal end of the scope as if the pedal of the irrigation pump was activated.Upon troubleshooting the issue during the case, the co2 flow from the insufflator was reduced from high to medium which resolved the spraying/leaking problem.There was no report of any patient injury.

• 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 30067-8764 ; 7709554400
• MDR Report Key: 25071343
• Report Number: 3020712480-2026-00019
• Device Sequence Number: 10357706
• Product Code: FEQ
• UDI-Device Identifier: 04065655000375
• UDI-Public: 04065655000375
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall,Notification
• Type of Report: Initial
• Report Date (Section B): 05/04/2026

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: W4466273
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2025
• 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
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Unknown
• Patient Weight: 68 KG