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

Catalog Number	20325-206
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a hybrid co2 tubing/cap sets for olympus® scopes leaked from the irrigation tubing at the distal end during a standard endoscopy.The set was used with an erbe endoscopy port connector for olympus® scopes (part number: 20325-211, lot number wo469953, date of manufacturing 10/20/2025, expiration date 10/01/2028, and udi (b)(4).Specifically, it was reported that the irrigation flow at the distal end of the scope was significant.Then, when applying very light pressure to the irrigation pump's pump head, the leaking ceased.Another irrigation pump was used which resolved the leaking.No patient injury was reported.
Additional Manufacturer Narrative
The set and port connector were not available for an evaluation.Nevertheless, based upon the reported information, the original irrigation pump was associated with the encountered leaking (note: the unit' pump head may have been worn and as such the tubing was not clamped down sufficiently in its head.It is also possible that there was variability with the set's tubing that interfaced with the pump head and/or the pump head which caused the head not to clamp down firmly on the tubing.).Other contributing causes of leaking at the end of scopes are also being investigated.In conclusion, no determination could be made as to the exact cause(s) of the reported problem.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: 25014173
• Report Number: 3020712480-2026-00020
• Device Sequence Number: 9542643
• Product Code: FEQ
• UDI-Device Identifier: 04065655000436
• UDI-Public: 04065655000436
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K132340
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/28/2026

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: 20325-206
• Device Lot Number: W4480069
• 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: 04/01/2026
• Initial Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2026
• 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