MAUDE Adverse Event Report: HOYA CORP PENTAX; VIDEO DUODENOSCOPE

Model Number ED-3490TR

Device Problems Device Reprocessing Problem (1091); Obstruction of Flow (2423); Device Contamination with Chemical or Other Material (2944)

Patient Problems Exposure to Body Fluids (1745); No Known Impact Or Consequence To Patient (2692)

Event Date 04/10/2014

Event Type  malfunction  

Event Description

A stent was removed during a ercp procedure nad was stuck inside this scope.The scope was brushed and cleaned by hospital staff and no stent was found.Later during another procedure that same stent fell out, therefore it was stuck somewhere inside this scope.This was reported by the hospital to tga in (b)(6) 2014, and tga sent inquiry to dt (pentax distributor in (b)(4)) on (b)(6) 2014.Pentax got dt's info on (b)(6) 2014.Pentax medical usa was made aware of the event on (b)(6) 2014.No adverse events have been reported to the pt or user, however due to pt exposure, pentax medical usa considers this event fda reportable.

Manufacturer Narrative

As per device technologies assessment: the scope has been returned to device technologies for assessment and repair.The mfr has been advised of the event and has been assisting with the investigation.As this is the only case of its kind and the investigations have found the damage sustained to the scope occurred outside of the conditions for normal/ recommended use, no further action is required at this time.Device technologies will continue to monitor this product in the market for any further adverse events.As per pentax medical's investigation: the duodenoscope was assessed by one of the pentax medical trained and accredited service technicians in the device technologies workshop.An inspection of the insertion tube showed severe damage.The damage was located at marker 4 (40cm mark from proximal end).The ift tube was severely squashed and punctured.In addition the operation/biopsy channel was severely damaged/bent.The damage sustained to the scope indicated external impact and misuse.Pentax will continue to monitor performance of the device.This event occurred in (b)(6) and no similar complaints have been received in the usa for user error/misuse for ed-3490tk.Pentax considers this medwatch report closed.

• Brand Name: PENTAX
• Type of Device: VIDEO DUODENOSCOPE
• Manufacturer (Section D): HOYA CORP; tokyo ; JA
• Manufacturer (Section G): HOYA CORP PENTAX LIFE CARE TOKYO OFFICE; 2-7-5 naka-psjao; shinjuku-ku; tokyo 161- 8525; JA 161-8525
• Manufacturer Contact: anastasia vlamis ; 3 paragon dr; montvale, NJ 07645 ; 2015712300
• MDR Report Key: 4301578
• MDR Text Key: 5197136
• Report Number: 2518897-2014-00008
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K092710
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Other,Health Professional
• Reporter Occupation: Not Applicable
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ED-3490TR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/25/2014
• Distributor Facility Aware Date: 07/10/2014
• Event Location: Hospital
• Date Report to Manufacturer: 07/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1