MAUDE Adverse Event Report: ERBE MEDICAL. LLC ERBE'S CO2 TUBING/CAP SETS

Catalog Number	20325-208
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the hybrid co2 tubing/cap sets for fujinon scopes leaked from the irrigation line.Also, caps are skipping threads and popping off when threaded on to baxter bottles if not done perfectly.Another similar product {hybrid co2 tubing/cap sets for fujifilm scopes, part number 20325-248, lot numbers w4467056 [date of manufacturing (dom) 08/28/25, expiration date 08/27/2028] and wo471252 (dom 10/16/25, expiration date 10/15/2028), udi: (b)(4)} was a part of the complaint.The sets were used with an erbe irrigation pump model eip2 and erbe co2 insufflator model eco2.No patient injuries were reported.
Additional Manufacturer Narrative
Sets were returned on 03/25/26 to erbe usa and forwarded to erbe medical llc on 04/01/26.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 leaking 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 the leaking, a follow-up mdr will be filed.In addition, if any other conclusions are ascertained upon the evaluation of the returned sets involved with the leaking, then a follow-up mdr will be filed.

• Brand Name: ERBE'S 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: 24799984
• Report Number: 3020712480-2026-00006
• Device Sequence Number: 10679167
• Product Code: FEQ
• UDI-Device Identifier: 04065655001099
• UDI-Public: 04065655001099
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Remedial Action: Notification,Recall
• Type of Report: Initial
• Report Date (Section B): 04/07/2026

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: 20325-208
• Device Lot Number: WO468760
• 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: 03/10/2026
• Initial Report FDA Received Date: 04/07/2026
• Date Device Manufactured: 09/17/2025
• 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