MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX VIDEO GASTROSCOPE

Model Number EG-2990I

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

Patient Problem Bacterial Infection (1735)

Event Date 01/01/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4). Because information received on 04/11/2016 identifies two endoscopes in relation to the same patient event, two mdrs are being filed. See 2518897-2015-00024, which was filed for video duodenoscope model #ed-3490tk, serial #(b)(4), and has been updated to reflect information on the two scopes.

Event Description

On 04/11/2016, (b)(4) received the following information regarding this event. On (b)(6) 2013, the patient had an endoscopic retrograde cholangiopancreatogram (ercp) procedure at (b)(6) using video duodenoscope model #ed-3490tk, serial #(b)(4) and video gastroscope model# eg-2990i, serial #(b)(4). From (b)(6) 2014, the patient was admitted to (b)(6). During this admission, the patient had a jp (jackson-pratt) drain culture positive for escherichia coli (metallo beta lactamase producing organism); a biliary drain culture positive for escherichia coli (metallo beta lactamase producing organism) and few klebsiella pneumoniae (carbapenemase producing organism); and pelvic drain and abdominal fluid cultures positive for klebsiella pneumoniae (carbapenemase producing organism). Patient was treated with antibiotics (tigecycline, colistin, and meropenem). From (b)(6) 2014, the patient was admitted to (b)(6). During this admission, the patient had left retro hepatic hematoma fluid and bile drainage cultures positive for klebsiella pneumoniae carbapenemase (kpc). From (b)(6) 2014, the patient was admitted to (b)(6). During this admission, the patient had a bile drainage culture positive for klebsiella pneumoniae (carbapenemase producing organism).

• Brand Name: PENTAX
• Type of Device: VIDEO GASTROSCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi; tokyo, 196-0 012; JA 196-0012
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi; tokyo, 196-0 012; JA 196-0012
• Manufacturer Contact: william "temporary" ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 5647038
• MDR Text Key: 44998836
• Report Number: 9610877-2016-00085
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/24/2018,04/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: EG-2990I
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/24/2018
• Distributor Facility Aware Date: 04/11/2016
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/24/2018
• Date Manufacturer Received: 04/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 05/11/2016 Patient Sequence Number: 1