MAUDE Adverse Event Report: OLYMPUS OLYMPUS; DUODENOSCOPE

Model Number TJF-Q180V

Device Problems Design/structure problem (1161); Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); Death (1802)

Event Date 01/12/2016

Event Type  Death  

Event Description

The pt underwent an ercp and endoscopic us on (b)(6) 2016 without any complications.On (b)(6) 2016, the pt presented to an outside hospital emergency department with complaint of diffuse radiating pain throughout with complaint of diffuse radiating pain throughout her abdomen (8/10) with associated nausea, vomiting, shortness of breath, and chills.Denied fever.She also had constipation with last bowel movement several days prior despite the use of laxatives.The pain started on the day of admission when the pt awoke around 3 am with abdominal pain.She took three doses of morphine but the pain persisted.She became increasingly lethargic and her family brought her into the ed for eval.Upon arrival, vital signs included: bp 68/42, hr 120, t 98.1 "f (36.7 degrees centigrade), rr 20, o2 saturation 96% on ra.Pt was given a fluid bolus with normal saline and was started on ertapenem 1000 mg iv.After discussion with the pt and her family, it was decided that pt would pursue comfort care.Care was transitioned to palliative care and the pt was discharged to home with her family and home hospice and expired on (b)(6) 2016.(b)(6) was not notified of the pt's death until 07/26/2016 from the pt's referring md.Infection control requested the outside hospital culture isolates for pfge testing.The isolate in this pt was identical to other esbl e.Coli that caused infections in pts who had undergone procedures with the same duodenoscope, olympus tjf-q180v-2202880.This issue has been reported previously to the mfr who reported this event to the fda.Appropriate state health officials have been notified as well.Prior to pt encounter, the scope was being leak tested and washed per mfr guidelines.Facility also performed atp testing.(b)(6) became aware of this pt's death after letters to exposed pts were sent and the pt's pcp informed us of her passing.Gi md called and spoke with the husband offering condolences and answering any questions he may have had.

• Brand Name: OLYMPUS
• Type of Device: DUODENOSCOPE
• Manufacturer (Section D): OLYMPUS; 2400 ringwood ave; san jose CA 95131 1700
• MDR Report Key: 5917834
• MDR Text Key: 53718899
• Report Number: 5917834
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 08/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-Q180V
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/02/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/25/2016
• Distributor Facility Aware Date: 07/26/2016
• Device Age: 4 YR
• Event Location: Home
• Date Report to Manufacturer: 08/25/2016
• 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 Outcome(s): Death
• Patient Age: 88 YR
• Patient Weight: 54