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

Model Number EB-1970UK

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 occurred in (b)(6) stating fail dry leak test-leakage for ultrasound video bronchoscope model eb-1970uk/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 inspector confirmed the customer's complaint of failed (dry) leak test which was found at the biopsy channel distal end.Other inspectional findings during evaluation included: failed wet leak test.Fluid invasion in segment section.Distal body chip at channel opening at thinnest part.Ultrasound transducer mild cut on probe.Umbilical cable long, buckle at umbilical connector side.Insertion tube buckles at stage 1.Umbilical cable junction casing top cracked.Umbilical cable junction casing bottom cracked.The pentax endoscope technician also confirmed a piece of brush lodged in the biopsy inlet piece.Pentax medical followed up with the customer for additional information regarding the piece of brush found lodged in the bronchoscope.The customer stated that they were not aware of the brush being lodged in the biopsy inlet t-piece.In addition, they stated that the equipment was purchased from a third-party vendor in (b)(6) 2015 and was imported to (b)(6) in (b)(6) of 2016.As soon as the bronchoscope arrived at their facility, the medical staff tested the equipment to confirm if it was in adequate working condition.As stated in the ifu for this bronchoscope model, "all instruments must be reprocessed prior to first time use, after any repairs/service and before every patient use.Before reprocessing and/or immersion in any fluids, pentax endoscopes should be tested for the loss of integrity in their watertight construction by using pentax brand leak testers." as soon as the bronchoscope failed the leak test, the customer reported it to pentax and obtained a quote for repair.The customer also stated the scope was never used on a patient.Repairs were performed on the bronchoscope which included replacement of the following components: o-rings and seals.Segment staycoil assy pb-free.Staycoil collar.Insertion flexible tube.Distal joint screw m1.Balloon feeder/return tube.Operation channel.Bending rubber.Staycoil assy attaching screw.Distal attaching plate.Light guide cable lg connector.Light guide cable long.Sub connector pb-free.Cn3/cn4/warning labels.Lg junction case top and bottom imp-1.Fwd body cover imp-1.Biopsy inlet piece imp-1.The ultrasound video bronchoscope was returned to the customer on (b)(6) 2016.

• Brand Name: PENTAX
• Type of Device: ULTRASOUND 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: 6644927
• MDR Text Key: 77733790
• Report Number: 9610877-2017-00040
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: EC
• PMA/PMN Number: K131946
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/15/2017,03/29/2016

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-1970UK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2016
• 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: 03/29/2016
• Event Location: Hospital
• Date Report to Manufacturer: 06/15/2017
• Initial Date Manufacturer Received: 03/29/2016
• Initial Date FDA Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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