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	05/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Endoscopy procedure: when priming the erbeflo clevercap tubing with water, for the endoscopy tower set up with co2, tubing would not prime.No water into tubing.Troubleshot tubing for 10 minutes without success and changed tubing and successfully primed.No harm to patient, delay in start of procedure.Manufacturer response for pump, air, non-manual, for endoscope, erbe (per site reporter) will obtain.

• Brand Name: ERBE
• Common Device Name: PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE
• Manufacturer (Section D): ERBE ELEKTROMEDIZIN GMBH; 2225 northwest pkwy.; marietta GA 30067
• MDR Report Key: 17142928
• Report Number: 17142928
• Device Sequence Number: 7663257
• Product Code: FEQ
• UDI-Device Identifier: 04050147020535
• UDI-Public: (01)04050147020535(17)260201(10)20230045
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/02/2023
• Report Date (Section F): 06/02/2023

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
• Operator of Device: Health Professional
• Device Model Number: 20325-239
• Device Catalogue Number: 20325-239
• Device Lot Number: 20230045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/16/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/16/2023
• 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: 06/02/2023