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

Model Number 20325-206

Device Problems Fluid/Blood Leak (1250); Structural Problem (2506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/23/2021

Event Type  malfunction  

Event Description

Erbeflo clevercap tubing was split hours after first inserted in erbe machine.Tubing needed to be adjusted, noting poor flow when stepping on pedal.Water leaked from under tower and flowed in hallway, after adjustment.Manufacturer response for disposable tubing, erbeflo clevercap tubing (per site reporter): they performed an investigation, acknowledged the problem and said it was identified that there is a problem in their molding process.

• Brand Name: ERBE
• Type of Device: PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE
• Manufacturer (Section D): ERBE ELEKTROMEDIZIN GMBH; 2225 northwest pkwy; marietta GA 30067
• MDR Report Key: 12646664
• MDR Text Key: 276851597
• Report Number: 12646664
• Device Sequence Number: 1
• Product Code: FEQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 20325-206
• Device Catalogue Number: 20325-206
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/07/2021
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 10/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other