MAUDE Adverse Event Report: OLYMPUS OLYMPUS DUODENOSCOPE 180; ERCP

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 07/15/2016

Event Type  malfunction  

Event Description

Through our routine microbiological surveillance cultures of duodenoscopes, we have identified an olympus duodenoscope (serial # (b)(4)) that has cultured (b)(4) for (b)(4) on 2 occasions despite several rounds of high level disinfection and sterilization.Once after our routine repeat high level disinfection process (2x hld) and then through the (b)(6) department of public health that the (b)(4) isolates only differed by three bands and are probably related.This despite 2 cycles of hld and one subsequent cycle of eo replacement of the elevator mechanism with the new parts per the fda recall.This duodenoscope was (b)(4) the last time it was cultured in december of 2015 (about 50 uses ago).From the information we have so far, we have not identified any adverse patient outcomes in patients who had this scope used on them between (b)(6) 2015 to present.

• Brand Name: OLYMPUS DUODENOSCOPE 180
• Type of Device: ERCP
• Manufacturer (Section D): OLYMPUS
• MDR Report Key: 5843105
• MDR Text Key: 51072563
• Report Number: MW5063811
• Device Sequence Number: 1
• Product Code: NWB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2016
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other