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

Model Number	EB-1170K
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
International medical device regulators forum (imdrf) adverse event reporting (b)(4).
Event or Problem Description
Pentax was made aware of a complaint on 25-mar-2021 of a "brush stuck/broken in channel" involving the pentax medical video bronchoscope, model eb-1170k, serial number (b)(4).The user facility responded to the good faith effort request via email on on 30-mar-2021, stating that the cleaning brush was an oem cleaning brush, model cs4010a, unknown lot number, size 1.8mm-3.2mm cleaning brush.The customer owned bronchoscope was returned for evaluation on 31-mar-2021.During evaluation of the endoscope under service order (b)(4), the pentax medical service repair technician found an "accessory stuck in primary operational channel and broken accessory blocking biopsy t-piece" confirming the customer's complaint and documenting the following additional findings on 01-apr-2021: umbilical cable buckle at control body side, umbilical cable buckle at umbilical connector side, up/ down brake lever cracked, up/ down control knob/ lever cracked, failed dry leak test, failed wet leak test, # 4 remote control button cover cracked, bending rubber leak at middle section, leak at # 1 remote control button cover, bending rubber cut, insertion tube buckles at end of root brace, insertion tube buckles at stage 3.The device underwent repairs including the following components: distal end assy with tubes, distal attaching pin, segment steel braid, insertion/s-nipple attaching screw, o-ring(1.25x3.5), suction connection tube, o-ring(1.2x3.5), light guide cable, friction lever assy, angle lever assy, r.C.Button (4) pb-free, biopsy inlet t-piece.This is the first time pentax model eb-1170k, serial number (b)(4) has been returned for serviced at a pentax facility since the device was put into service on (b)(6) 2013.Instructions for use(ifu), includes the following warning section "after using operational/cleaning accessories (e.G., forceps, needles, snares, brushes etc.) with the endoscope, carefully check that all accessories are intact and that no parts have fallen off and become lodged within the endoscope's instrument/suction channel.Furthermore, ensure that any therapeutic devices (e.G., clips, stents, etc.) passed through the channel are accounted for after use.On 06-apr-2016, pentax issued a u.S.Urgent field correction which is an ifu addendum for endoscopes with instrument channels.This addendum covers any operational/cleaning accessories and therapeutic devices which can become lodged in the endoscope's instrument channel.It reminds customers to carefully check that all accessories are intact, that no parts have fallen off and become lodged within the endoscope's instrument/suction channel and to ensure that any therapeutic devices (e.G., clips, stents, balloons, etc.) passed through the instrument channel and are accounted for after use.The endoscope is awaiting repair and approved by final qc as of 24-apr-2021.

• Brand Name: PENTAX
• Common Device Name: VIDEO BRONCHOSCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• MDR Report Key: 11721617
• Report Number: 9610877-2021-00077
• Device Sequence Number: 3193292
• Product Code: EOQ
• UDI-Device Identifier: 04961333232154
• UDI-Public: 04961333232154
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: D216953
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/25/2021

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
• Operator of Device: Health Professional
• Device Model Number: EB-1170K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 04/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1