MAUDE Adverse Event Report: ERBE ELEKTROMEDIZIN GMBH ERBE; PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE

Model Number	20325-239
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Erbeflo clevercap tubing was broke when we opened the package.One of the tubes is broke/sliced near the blue cap.

• Brand Name: ERBE
• Common Device Name: PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE
• Manufacturer (Section D): ERBE ELEKTROMEDIZIN GMBH; 2225 northwest parkway; marietta GA 30067
• MDR Report Key: 18571012
• Report Number: 18571012
• Device Sequence Number: 12531804
• Product Code: FEQ
• UDI-Device Identifier: 04050147020535
• UDI-Public: (01)04050147020535(17)260501(10)20230193-PG
• 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): 10/06/2023
• Report Date (Section F): 10/06/2023

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
• Device Model Number: 20325-239
• Device Catalogue Number: 20325-239
• Device Lot Number: 20230193-PG
• 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: 01/24/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/24/2024
• 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 Sex: Unknown
• Date Report Sent to FDA: 10/06/2023