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

Model Number ED-3490TK

Device Problems Device Reprocessing Problem (1091); Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

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.

• Brand Name: PENTAX
• Type of Device: VIDEO 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; JA 987-2203
• Manufacturer Contact: 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 3457417
• MDR Text Key: 3736493
• Report Number: 2518897-2013-00005
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K092710
• Number of Events Reported: 1
• Summary Report (Y/N): N
• 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 Received: 10/28/2013
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: ED-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 FDA: 10/28/2013
• Distributor Facility Aware Date: 09/30/2013
• Device Age: 3 mo
• Event Location: Hospital
• Date Report TO Manufacturer: 10/28/2013
• Date Manufacturer Received: 09/30/2013
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 08/01/2013
• 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