MAUDE Adverse Event Report: HOYA CORP. PENTAX VIDEO DUODENOSCOPE

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.

• Brand Name: PENTAX
• Type of Device: VIDEO 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 Key: 4944875
• MDR Text Key: 112334533
• Report Number: 2518897-2015-00023
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 07/24/2015
• 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 FDA: 09/25/2015
• Distributor Facility Aware Date: 07/13/2015
• Event Location: Hospital
• Date Report to Manufacturer: 09/25/2015
• Date Manufacturer Received: 07/15/2015
• 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