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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOYA CORP. PENTAX VIDEO DUODENOSCOPE

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HOYA CORP. PENTAX VIDEO DUODENOSCOPE Back to Search Results
Device Problem Microbial Contamination of Device (2303)
Patient Problem Bacterial Infection (1735)
Event Date 01/01/2013
Event Type  Injury  
Event Description
On 09/03/2015, pentax medical received information regarding this event which confirmed this patient underwent an ercp procedure on (b)(6) 2013. In addition, patient information, which included the patient identifier (mrn#(b)(6)) and date of birth, were also confirmed. (b)(4). Cre infections arising out of (b)(6) were the subject of multiple previous mdrs and related investigations; see 30-day mdr#'s 2518897-2013-00004, 2518897-2013-00005, 2518897-2013-00006, 2518897-2014-00001, and 2518897-2014-00002 filed on 09/20/2013, 10/28/2013, 11/12/2013, 03/06/2014, 03/06/2014, respectively. On 07/13/2015, pentax medical was served with a legal complaint (summons) for an injury regarding a patient undergoing a procedure at (b)(6) in 2013, but insufficient information was provided at that time to identify the patient or match the patient to patients that were previously the subject of the referenced mdrs. As a result, mdr 2518897-2015-00023 was filed for this patient with the information received 07/13/2015 through the legal complaint (summons). With the receipt of the additional information on 09/03/2015, pentax medical has been able to confirm that this patient corresponds with patient previously reported in a prior mdr (mdr 2518897-2013-00004, follow up#2). Therefore, going forward pentax medical will cease supplementing the present mdr and will report supplemental information on this patient exclusively to mdr 2518897-2013-00004.
 
Event Description
On (b)(6) 2015, pentax medical was served with a complaint (summons) for a injury regarding a patient treated at (b)(6) hosp. The complaint alleges that the duodenoscope (not specified) used on the patient had been contaminated with carbapenem-resistant enterobacteriaceae (cre). The complaint further alleges that after the procedure performed on or about (b)(6) 2013, the patient developed a cre infection. Patient is represented by counsel. Due to the filing of a lawsuit, pentax will supplement this mdr report with additional information as it is received through formal discovery. Cre infections arising out of (b)(6) were the subject of multiple previous mdrs and related investigations; see 30-day mdr#'s 2518897-2013-00004, 2518897-2013-00005, 2518897-2015-00006, 2518897-2014-00001, and 2518897-2014-00002 filed on (b)(6) 2013, (b)(6) 2013, (b)(6) 2013, (b)(6) 2014, (b)(6) 2014, respectively. However, the patient identified in the lawsuit complaint received by pentax cannot be matched to patients that were previously the subject of the referenced mdrs.
 
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Brand NamePENTAX
Type of DeviceVIDEO DUODENOSCOPE
Manufacturer (Section D)
HOYA CORP.
tokyo
JA
Manufacturer (Section G)
PENTAX LIFE CARE TOKYO OFFICE
2-7-5 naka-psjao
shinjuku-ku
tokyo 161-8 525
JA 161-8525
Manufacturer Contact
anastasia vlamis
3 paragon dr.
montvale, NJ 07645
2015712300
MDR Report Key4944875
MDR Text Key112334533
Report Number2518897-2015-00023
Device Sequence Number1
Product Code FDT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Source Type Consumer,consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/25/2015,07/13/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/25/2015
Distributor Facility Aware Date07/13/2015
Event Location Hospital
Date Report to Manufacturer09/25/2015
Date Manufacturer Received07/15/2015
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/24/2015 Patient Sequence Number: 1
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