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	04/09/2026
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 of scopes during endoscopy.Another lot of the same part number (lot number wo470913, date of manufacturing 10/13/2025, and expiration date 10/12/2028) was also reported to have leaked during procedures.The sets were used with a co2 insufflator [model eco 2 plus, part number 2n100-068) set on high co2 flowrate as well as an irrigation pump (model eip 2, part number 10325-000).In addition, the sets were used with a port connector (part number 20325-211).No patient injuries were reported.
Additional Manufacturer Narrative
The sets were not available for an evaluation.Nevertheless, we have 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 any 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 30067-8764 ; 7709554400
• MDR Report Key: 25071321
• Report Number: 3020712480-2026-00021
• Device Sequence Number: 10689189
• 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,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Notification,Recall
• 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: W4469443
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2025
• 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