MAUDE Adverse Event Report: OLYMPUS E R C P; DUODENOSCOPE

Model Number TJF160F

Device Problem Insufficient Information (3190)

Patient Problem Bacterial Infection (1735)

Event Date 07/11/2015

Event Type  Injury  

Event Description

As reported in a letter to (b)(6) public health on (b)(6) 2015 by (b)(6), rn, bs, phn, cphq, cic, infection control preventionist, three patients were admitted with septicemia following ercp procedures.The patients were positive for similar multi-drug resistant pseudomonas.

• Brand Name: E R C P
• Type of Device: DUODENOSCOPE
• Manufacturer (Section D): OLYMPUS; 3500 corporate parkway p.o box 610; center valley PA 18034 0610
• MDR Report Key: 5038267
• MDR Text Key: 24365067
• Report Number: 5038267
• Device Sequence Number: 1
• Product Code: FDT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Report Date: 08/21/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TJF160F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/21/2015
• Distributor Facility Aware Date: 07/20/2015
• Event Location: Hospital
• Date Report to Manufacturer: 08/21/2015
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR