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U.S. Department of Health and Human Services

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

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HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO GASTROSCOPE Back to Search Results
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).
 
Event Description
On 25-oct-2016, device history review was performed confirming the gastroscope was manufactured under normal conditions, passed all required inspections, and was released accordingly.Also, there were no reworks or concessions and the dates of approval for shipment and actual date shipped were confirmed.No further information has been received for this event, therefore, pentax considers this medwatch report closed.
 
Manufacturer Narrative
Report source continued: hoya corporation pentax tokyo office, specification developer, registration no.(b)(4).Pentax of america, inc., importer, registration no.(b)(4).Pentax of america, inc.(importer) is submitting the report on behalf of hoya corporation pentax tokyo office (exemption number e2015036).
 
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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
MDR Report Key5647038
MDR Text Key44998836
Report Number9610877-2016-00085
Device Sequence Number1
Product Code FDS
Combination Product (y/n)N
PMA/PMN Number
K131902
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
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 Received05/11/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberEG-2990I
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/24/2018
Distributor Facility Aware Date04/11/2016
Device Age6 YR
Event Location Hospital
Date Report to Manufacturer05/24/2018
Date Manufacturer Received04/11/2016
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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