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

Model Number EB-1570K

Device Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 10/31/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).This mdr was initiated as part of a capa-driven remediation effort related to filing of mdrs for complaints/events outside of the us (ous).As part of this remediation, pentax medical performed a retrospective mdr assessment of all ous events/complaints received since jan 2013.The retrospective assessment of this event prompted pentax medical to file this report.

Event Description

Pentax medical was made aware of a report for an event which occurred in (b)(6) stating, "went to take brushings from lung, was pushing brush along biopsy channel - when 5mm 'foreign object' appeared on screen.Photograph taken, object retrieved.Bronchoscope removed and replaced.Object retained and identified as ring from 'pull thru' brush," involving pentax model eb-1570k/serial (b)(4).The facility removed the non-pentax brand pull thru brushes from use until completion of their investigation.

Manufacturer Narrative

(b)(4).

Event Description

Pentax (b)(4) concluded the event was caused by a non-approved 3rd party device (non-pentax brand pull thru brush).On (b)(6) 2016, a device history review was performed which confirmed the bronchoscope was manufactured under normal conditions.The bronchoscope failed in-process inspection for water leaking, was reworked where the k-pipe was reconnected, subsequently passed all required inspections, and was released accordingly.In addition, there were no additional 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 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: 5499204
• MDR Text Key: 40299516
• Report Number: 9610877-2016-00067
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K131028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/26/2017,10/31/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EB-1570K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/26/2017
• Distributor Facility Aware Date: 10/31/2013
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/26/2017
• Initial Date Manufacturer Received: 10/31/2013
• Initial Date FDA Received: 03/14/2016
• Supplement Dates Manufacturer Received: 10/31/2013
• Supplement Dates FDA Received: 07/26/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/09/2010
• 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
• Patient Outcome(s): Required Intervention