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

Model Number EB-1570K

Device Problems Device Reprocessing Problem (1091); Obstruction of Flow (2423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This mdr was initiated as part of a capa-driven remediation effort related to filing of mdrs for complaints/events related to lodged material remaining in endoscopes after reprocessing.As part of this remediation, pentax medical performed a retrospective mdr assessment of events/complaints received from (b)(6) 2014-(b)(6) 2016.The retrospective assessment of this event prompted pentax medical to file this report.

Event Description

Pentax medical was made aware of a complaint which stated fail dry leak test - pinhole leak for video bronchoscope model eb-1570k/serial (b)(4) received through the pentax medical service department.No other information was provided at the time of the report.The bronchoscope was returned to pentax medical for evaluation.The pentax endoscope technician confirmed a cleaning brush (non-pentax) lodged inside the aft tube near the biopsy inlet t-piece area.Other inspectional findings included: bending rubber pinhole.Failed dry/wet leak tests.Lightguide prong cover glass set loose.Ccd circuit board color adjustment required.Bending rubber leak at distal end.Follow-up was conducted with the facility to gather additional information.Responses were received on (b)(6) 2015 stating the user was not aware the brush was lodged in the bronchoscope, and, as a result, the potential of possible exposure to multiple patients existed.The facility also stated that no patients who had contact with the bronchoscope have reported any symptoms of illness or injury to date.A letter was received from the facility on 08/25/2015 requesting return of the non-pentax brush.Since pentax medical was clearly not the rightful owner, and since the brush originated from the facility, the brush was returned to the customer to be maintained as their property.Furthermore, the brush appears to be nearly identical in design to the brush the facility reported using ((b)(4) medical brush).Although not proven, the difference in color of the tips, when comparing a photo of a new brush to the returned brush, may be likely the result of prolonged chemical exposure.The bronchoscope has no previous history since this was the first customer to receive this bronchoscope after shipment from pentax medical on (b)(6) 2015.In addition, a device history review was performed on (b)(6) 2015 confirming the bronchoscope 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.Repairs were performed on the bronchoscope which included replacement of the following components: o-rings and seals.Bending rubber.Insertion/s-nipple attaching screw.Suction connection tube.The bronchoscope was delivered to the customer on (b)(6) 2015.The reprocessing ifu for this bronchoscope clearly states "do not use cleaning brushes other than those that are specified in this instruction for use".No further information has been received for this event, therefore, pentax medical considers this medwatch report closed.

• Brand Name: PENTAX
• Type of Device: VIDEO BRONCHOSCOPE
• 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: matthew vernak ; 3 paragon drive; montvale, NJ 07645 ; 2015712300
• MDR Report Key: 6644842
• MDR Text Key: 77725905
• Report Number: 9610877-2017-00036
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/15/2017,08/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EB-1570K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/15/2017
• Distributor Facility Aware Date: 08/24/2015
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/15/2017
• Initial Date Manufacturer Received: 08/24/2015
• Initial Date FDA Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1