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	02/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sets were returned to the manufacturer for analysis.Specifically, 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 any 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 & co2 intermittently over the past 4 weeks, there is a continuous irrigation stream.Physicians have complained about it during procedures that it distorts their visualization.The staff have complained that it will leak from distal end of scope while waiting for procedure to start.Other lot numbers of the same part number [lot number (l/n) w4466273, date of manufacturing (dom) 08/18/25, and expiration date (exp.Date) 08/17/28; l/n w4466275, dom 08/18/25, and exp.Date 08/17/28; l/n w4466814, dom 08/26/25, and exp.Date 08/25/28; l/n w4467680, dom 09/05/25, and exp.Date 09/04/28; l/n wo463714, dom 07/17/25, and exp.Date 07/16/28; as well as l/n wo468776, dom 09/17/25, and exp.Date 09/16/28] were also a part of the complaint.There were no reports of any patient injuries.

• 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: 24911797
• Report Number: 3020712480-2026-00011
• Device Sequence Number: 15934910
• Product Code: FEQ
• UDI-Device Identifier: 04065655000375
• UDI-Public: 04065655000375
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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 Health Care Professional
• Remedial Action: Notification,Recall
• Type of Report: Initial
• Report Date (Section B): 04/17/2026

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: W4466004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2026
• 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: 04/17/2026
• Date Device Manufactured: 08/13/2025
• 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