MAUDE Adverse Event Report:; DSD EDGE AER

Device Problems Device Reprocessing Problem (1091); Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 10/14/2015

Event Type  Injury  

Event Description

Gi procedure area: incomplete high level disinfection (hld) cycle of endoscope as dsd edge automatic endoscopic reprocessor machine's lid was able to be open during (hld) to retrieve the scope prior (hld) cycle was completed.

• Type of Device: DSD EDGE AER
• MDR Report Key: 5273081
• MDR Text Key: 32996138
• Report Number: MW5058337
• Device Sequence Number: 1
• Product Code: FEB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/02/2015
• Type of Device Usage: N
• Patient Sequence Number: 1