MAUDE Adverse Event Report: MEDIVATOR MINNTECH DSD EDGE

Device Problem Insufficient Information (3190)

Patient Problem Bacterial Infection (1735)

Event Date 07/08/2016

Event Type  malfunction  

Event Description

During week of (b)(6) 2016 three patients had a bronchoscopy.The three patients all had different scopes used.One patient culture positive for nocardia and two patients tested positive for tsukmurella.Common equipment used to clean the three scopes was medivator dsd edge, mfg.Minntech.Serial (b)(4).

• Brand Name: MINNTECH DSD EDGE
• Type of Device: MINNTECH DSD EDGE
• Manufacturer (Section D): MEDIVATOR
• MDR Report Key: 5948992
• MDR Text Key: 54790397
• Report Number: MW5064716
• 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: 09/12/2016

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 Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/12/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other