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 12/09/2015

Event Type  Death  

Event Description

Pt with history of ercp with stenting (including (b)(6) 2013) transferred from an outside hospital with septic shock on (b)(6).Blood cultures drawn prior to transfer positive for e.Coli, klebsiella pneumoniae, and clostridium perfringens.Prior to transfer underwent ercp on (b)(6) with removal of sludge/stones occluded stent and placement of 3 new plastic stents.She was able to be discharged on (b)(6).On (b)(6) 2016, (b)(6) was informed by the pt's daughter that she had passed away in the ltac on (b)(6) 2016.Daughter did not disclose the cause of death but given the pt's recent hospitalization and condition, (b)(6) believes it is likely correlated to ercp and resulting esbl e coli infections.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 and the fda.Appropriate state health officials have been notified as well.Prior to pt encounters, the scope was being leak tested and washed per mfr guidelines.Facility also performed atp testing.On august 22, 2016 (b)(6) was informed by the pt's daughter that she had passed away in the ltac on (b)(6) 2016.Daughter did not disclose the cause of death but given the pt's recent hospitalization and condition, (b)(6) believes it is likely correlated to ercp and resulting esbl e coli infections.

• Brand Name: OLYMPUS
• Type of Device: DUODENOSCOPE
• Manufacturer (Section D): OLYMPUS ; 2400 ringwood ave; san jose CA 95131 1700
• MDR Report Key: 5917835
• MDR Text Key: 53722065
• Report Number: 5917835
• 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
• 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: 08/22/2016
• Device Age: 4 YR
• Event Location: Nursing 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: 71 YR
• Patient Weight: 59