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

Model Number	20325-239
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was cracked at the screw cap that inserts into the scope and water would shoot out during use of the water pedal.

• 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: 20309056
• Report Number: 20309056
• Device Sequence Number: 21028524
• Product Code: FEQ
• UDI-Device Identifier: 04065655000375
• UDI-Public: (01)04065655000375(17)261023(10)W0415682
• 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): 06/21/2024
• Report Date (Section F): 06/21/2024

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: W0415682
• 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: 09/26/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/26/2024
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 1 KG
• Date Report Sent to FDA: 06/21/2024