MAUDE Adverse Event Report: HOYA CORP PENTAX; VIDEO BRONCHOSCOPE

Model Number EB-1170K

Device Problems Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923)

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

Event Type  malfunction  

Event Description

Pentax medical received a report on (b)(6) 2015 stating that the suction valve popped out of the suction cylinder during irrigation using a 10ml syringe on the biopsy port.Emails were sent to (b)(4), territory manager on (b)(4) 2015 to confirm details surrounding the event.On (b)(6) 2015, confirmation from the territory manager was received stating that the event occurred during procedure, which could lead to possible cross contamination, due to the fluid ejecting from the suction cylinder.The video bronchoscope was evaluated by the pentax service department on (b)(4) 2015 by infusing water, slowly and with force, on the biopsy port using a 10ml syringe.The event was able to be duplicated when force was used to infuse the water.Repairs not related to the reported event were completed, and the video bronchoscope was returned to the customer on (b)(4) 2015.Since there are no relevant repairs to address this concern, a corrective action request will be submitted to the manufacturer to investigate the product malfunction and provide further guidance on how this product malfunction can be prevented from recurring.

Event Description

Due to force being a subjective phenomenon, a corrective action request was initiated on 05/04/2015 and will be submitted to the mfr to investigate the product malfunction.Based on the info received from the initial reporter and the findings by pentax medical, a definitive root cause of the reported event cannot be determined at this time.It is reasonable to suggest that the user introduced the fluid through the syringe with force, which caused the suction valve to pop out of the suction cylinder, as also confirmed by the pentax medical inspector when the video bronchoscope was evaluated.Pentax medical has not received any other info regarding this event or the video bronchoscope involved, and therefore considers this medwatch report closed.

• Brand Name: PENTAX
• Type of Device: VIDEO BRONCHOSCOPE
• Manufacturer (Section D): HOYA CORP; tokyo ; JA
• Manufacturer (Section G): HOYA CORP; 2-7-5 naka-psjao; shinjuku-ku, tokyo 161-8 525; JA 161-8525
• Manufacturer Contact: anastasia vlamis ; 3 paragon drive; montvale, NJ 07645 ; 2015712300
• MDR Report Key: 4769110
• MDR Text Key: 5949148
• Report Number: 2518897-2015-00005
• 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: Distributor
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/01/2015,04/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EB-1170K
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/07/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/01/2015
• Distributor Facility Aware Date: 04/15/2015
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/01/2015
• Date Manufacturer Received: 04/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1