MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; FIBERSCOPE

Model Number FB-8V

Device Problem Failure to Disconnect (2541)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.

Event Description

Pentax medical was made aware of a complaint on 25-feb-2020 regarding "brush stuck/broken in channel", involving pentax medical fiber bronchoscope, model fb-8v, serial number (b)(4).The end user stated that they experienced the failure during reprocessing.No patient involvement.The customer owned fiberscope was returned for evaluation on 05-mar02020.During evaluation of the endoscope under service order (b)(4), the pentax medical service repair technician found an "accessory stuck in primary operational channel" as noted 3 full and one half broken brush fibers, confirming the customer's complaint and documenting the following additional findings on 06-mar-2020: primary operation channel hole, leak at biopsy channel (large/ primary) distal side, insertion tube buckles at stage 1, some functions cannot be checked unit compromised by fluid, ocular assy scratched, suction function not performed unit compromised.The device underwent repairs including the following components: o-rings and seals, insertion flexible tube w/segment, segment steel braid, operation channel, distal attaching pin, bending rubber, screen mask.On 09-nov-2020, a device history record(dhr) review for model fb-8v, serial number (b)(4) was performed under ivai-20-110023, the dhr review confirmed the endoscope was manufactured on 03-oct-2008 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 for 06-oct-2008.Pentax medical model fb-8v, serial number (b)(4) has been routinely serviced at a pentax facility since the device was put into service on 22-oct-2008.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 fiberscope was delivered to the customer on 01-apr-2020 under delivery order (b)(4).

• Brand Name: PENTAX
• Type of Device: FIBERSCOPE
• 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: william goeller (temporary) ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 10840080
• MDR Text Key: 266249290
• Report Number: 9610877-2020-00214
• Device Sequence Number: 1
• Product Code: GDB
• UDI-Device Identifier: 04961333083640
• UDI-Public: 04961333083640
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: D077576
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/25/2020

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: FB-8V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2020
• Initial Date FDA Received: 11/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2008
• 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