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

Model Number	FB-18V
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Pentax medical was made aware of an event that occurred during pre-procedural inspection in the united states.The reported complaint received under notification (b)(4) for accessory stuck in scope "white pieces stuck in does not know what exactly it is", involving the pentax medical fiberoptic bronchoscope, model fb-18v, serial number (b)(4).The user facility responded to a gfe request via email on 09-oct-2020, and stated the white pieces stuck in the endoscope were found during the pre-inspection check and removed from circulation immediately after the failure/event occurred and subsequently called in for service/replacement.No serious injury or death of a patient or user, or delay in a procedure which would require medical intervention was reported.The customer owned fiberoptic bronchoscope was returned for evaluation on 05-oct-2020.During evaluation of the endoscope under service order (b)(4), the pentax medical service repair technician was unable to confirm the customers experience and documented the following findings on 06-oct-2020: image alignment out, passed wet leak test, passed dry leak test.The device underwent repairs including the following components: o-rings and seals on 15-oct-2020, a device history record(dhr) review for model fb-18v, serial number (b)(4) was performed under ivai-20-100069, the dhr review confirmed the endoscope was manufactured on 08-aug-2017 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 (b)(6) 2017.Pentax model fb-18v, serial number (b)(4) has been routinely serviced at a pentax facility since the device was put into service on (b)(6) 2018.Instructions for use(ifu), includes the following warning section 2-1-3, 3) "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 bronchoscope was delivered to the customer on (b)(6) 2020 under delivery order (b)(4).

• Brand Name: PENTAX
• Common Device Name: BRONCHO FIBERSCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• MDR Report Key: 10806329
• Report Number: 9610877-2020-00181
• Device Sequence Number: 3680842
• Product Code: EOQ
• UDI-Device Identifier: 04961333083527
• UDI-Public: 04961333083527
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K951199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/09/2020

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
• Operator of Device: Health Professional
• Device Model Number: FB-18V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 11/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1