MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II DUODENOVIDEOSCOPE

Model Number TJF-Q180V

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Blood Loss (2597)

Event Date 11/10/2014

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation or service at this time.An olympus endoscopy support specialist (ess) visited the site to assess the reprocessing practices at the user facility and provided training and education to the user facility staff on the following dates: january 30, 2015, january 31, 2015 and february 03, 2015.The ess noted reprocessing inconsistencies during the site visit.Olympus followed up with user facility to obtain additional information regarding the reported event by telephone and in writing but with no results.

Event Description

Olympus received (b)(4) which reports that a patient became infected with (b)(6) after undergoing an endoscopic retrograde cholangiopancreatography (ercp) and esophagogastroduodenoscopy (edg) procedure using a duodenvideoscope.It was reported that six days after the procedure the patient presented to the emergency room and was admitted to the hospital with hematemesis, epigastric pain radiating through the right upper quadrant.The patient was found to have a gi bleed.The patient underwent a blood transfusion and was administered fresh frozen plasma (ffp).On day two of admission the patient began to display signs of fever and was transferred to the medical intensive care unit (micu) and started on bipap.The patient's intravenous antibiotic was changed from zosyn to meropenem.The patient continued to exhibit high fevers associated with rigoring and was intraoperatively found to have a puss filled necrotic gallbladder.A subtotal cholecystectomy was performed with a mallinkodt drain within the gallbladder infundibulum.The pancreatic drain was replaced, with a pancreatic debridement.It was determined that by hospital day 40 the patient was no longer actively infected but was colonized with (b)(6).The patient was discharged to a skilled nursing facility in stable condition.In the same medwatch report the user facility reported that after an epidemiologic and microbiologic investigation conducted by the user facility on all of the cre patients; the user facility reported a cluster of patients were identified with klebsiela pneumonia.The user facility reported that all eight of the patients had undergone ercp procedures with a duodenvideoscope approximately within a three month period.

• Brand Name: EVIS EXERA II DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: donny shapiro ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-516
• MDR Report Key: 5729389
• MDR Text Key: 47529327
• Report Number: 2951238-2016-00501
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TJF-Q180V
• Device Catalogue Number: TJF-Q180V
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/23/2016
• Initial Date FDA Received: 06/16/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR