MAUDE Adverse Event Report: ERBE MEDICAL, LLC ERBEFLO CLEVERCAP®; PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE

Model Number	20325-239
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Tubing was leaking.

• Brand Name: ERBEFLO CLEVERCAP®
• Common Device Name: PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE
• Manufacturer (Section D): ERBE MEDICAL, LLC; 405 w geneva dr; tempe AZ 85282
• MDR Report Key: 20350699
• Report Number: 20350699
• Device Sequence Number: 7931506
• Product Code: FEQ
• UDI-Device Identifier: 04065655000375
• UDI-Public: (01)04065655000375(17)270104(10)W4422550
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2024
• Report Date (Section F): 09/11/2024

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 Model Number: 20325-239
• Device Catalogue Number: 20325-239
• Device Lot Number: W4422550
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/02/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/02/2024
• 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: 59 YR
• Patient Sex: Female
• Patient Weight: 71 KG
• Date Report Sent to FDA: 09/11/2024