MAUDE Adverse Event Report: ERBE MEDICAL. LLC ERBEFLO CLEVERCAP® HYBRID CO2 TUBING/CAP SETS

Catalog Number	20325-248
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an incident occurred with a hybrid co2 tubing/cap set for fujifilm scopes being used for an upper gi procedure.The set was used with a 700 series fuji scope, mv stratus co2 insufflator, and an erbe irrigation pump model eip 2 for an upper gi procedure.Specifically, leaking occurred from both scope buttons as well as out the distal end of the scope.Upon changing the tubing/cap set, the leaking ceased.No patient injury was reported.
Additional Manufacturer Narrative
The set was 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.In addition, reasons for leaking from scope buttons are also under investigation.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: 24875243
• Report Number: 3020712480-2026-00008
• Device Sequence Number: 21337159
• Product Code: FEQ
• UDI-Device Identifier: 04065655001006
• UDI-Public: 04065655001006
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/14/2026

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: 20325-248
• Device Lot Number: WO460905
• 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: 03/23/2026
• Initial Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2025
• 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