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	03/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sets have not been returned for analysis.However, 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.In this reported case, the sets are not intended to be used with bipolar gold probes (but only with erbe accessories and designated water bottles and scopes).Most likely, the change of the set's connector is associated with the reported issue; nevertheless, the use of the sets with bipolar gold probes is off label.If devices are returned and 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 sets for olympus® scopes uncontrollably leaked.Specifically, when the irrigation tubing of a set is connected to a bipolar gold probe, it leaks from the probe.Another lot of the same part number [lot number (l/n) wo471077, date of manufacturing (dom) 10/14/25, and expiration date (exp.Date) 10/13/28 was also a part of the complaint.The sets were also being used with a co2 olympus® connector tubes (part number 20325-219, udi: (b)(4), l/n wo458250, dom 05/13/25, and exp.Date 05/12/28; l/n wo465958, dom 08/13/25, and exp.Date 08/12/28; as well as l/n wo465959, dom 08/13/25, and exp.Date 08/12/28).No injury to any patient was reported.

• 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: 24941771
• Report Number: 3020712480-2026-00016
• Device Sequence Number: 20246765
• Product Code: FEQ
• UDI-Device Identifier: 04065655000436
• UDI-Public: 04065655000436
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Nurse
• Remedial Action: Notification,Recall
• Type of Report: Initial
• Report Date (Section B): 04/21/2026

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: WO470770
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2025
• 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