• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENTAX OF AMERICA, INC. PENTAX VIDEO DUODENOSCOPE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PENTAX OF AMERICA, INC. PENTAX VIDEO DUODENOSCOPE Back to Search Results
Model Number ED-3490TK
Device Problems Device Reprocessing Problem; Microbial Contamination of Device
Event Date 09/17/2013
Event Type  Injury  
Event Description

On (b)(6) 2013, user facility reported an event as follows: patient underwent an endoscopic retrograde cholangiopancreatography (ercp) procedure (date unknown) and developed a carbapenem-resistant enterobacteriaceae (cre) infection. The patient received antibiotics. No further information is available at this point about the patient. (b)(4) found behind elevator on scope. During a conference call with advocate on (b)(6) 2013 pentax was informed that one patient developed carbapenem-resistant enterobacteriaceae (cre) infection after undergoing ercp procedures using scope ed-3490tk, a110574. Additional twelve patients were screened for cre; nine patients screened negative and 3 patients screened positive for cre but did not develop a cre infection. The scope was tested at the user facility and positive culture was found behind the elevator and through the hole of the scope. Customer confirmed that non-pentax brushes are used to manually reprocess the pentax scopes. The cleaning brushes used at the facility are medivators. In addition, surg-enz is the enzymatic detergent/cleaner used to reprocess the scopes and is not on the pentax approved list of detergents. Cidex opa is used for high level disinfection. According to the pentax reprocessing/maintenance instruction for use (ifu), it specifically states that user must "be aware that all recessed areas around the elevator mechanism should be thoroughly cleaned with an appropriately sized cylinder cleaning brush (e. G. Csc9s) and in a cleaning detergent solution. ".

 
Manufacturer Narrative

Endoscope was evaluated by user and bacterial culture (cre) was found behind elevator. The actual scope has not yet been evaluated by pentax. Investigation is still ongoing. Additional information: title is manager of infection control and epidemiology.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePENTAX
Type of DeviceVIDEO DUODENOSCOPE
Manufacturer (Section D)
PENTAX OF AMERICA, INC.
montvale NJ
Manufacturer (Section G)
HOYA CORPORATION PENTAX MIYAGI FACTORY
30-2 okada aza-shimomiyano
tuskidate, kurihara-shi, miyagi 987- 2203
JAPAN 987-2203
Manufacturer Contact
3 paragon drive
montvale , NJ 07645
8004315880
MDR Report Key3457417
Report Number2518897-2013-00005
Device Sequence Number1
Product CodeFDT
Report Source Distributor
Source Type Health Professional,User facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/28/2013,09/30/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/28/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberED-3490TK
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/28/2013
Distributor Facility Aware Date09/30/2013
Device Age3 mo
Event Location Hospital
Date Report TO Manufacturer10/28/2013
Date Manufacturer Received09/30/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 10/28/2013 Patient Sequence Number: 1
-
-