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

Model Number	EB-1975K
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Viral Infection (2248)
Date of Event	01/30/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Pentax medical became aware of a report on (b)(6) 2020 stating, "possible contamination-patient tested positive for virus.Harboring infection." involving video bronchoscope model eb-1975k/serial (b)(4).The customer owned bronchoscope was received by pentax medical for evaluation on 05-feb-2020.The bronchoscope was inspected by pentax medical service on 14-feb-2020 and the following inspection findings were documented: insertion tube mild crush at stage 2, insertion tube mild crush at stage 1, passed wet leak test, passed dry leak test.The bronchoscope underwent repairs including the following components: distal end assy with tube, distal joint screw m1, bending rubber, biopsy inlet t-piece, o-rings and seals, insertion/s-nipple attaching screw, o-ring(1.25x3.5), suction connection tube, o-ring(1.2x3.5).The video bronchoscope is currently awaiting organic sampling and qc final approval as of 25-feb-2020.Pentax medical video bronchoscope, model eb-1975k, serial number (b)(4), has been previously serviced at a pentax facility once prior since the device was put into service on 23-mar-2017.
Event or Problem Description
Refer to h10.
Additional Manufacturer Narrative
Correction information: b4: date of this report.B5.Refer to h10.F7: follow up #01.F11: updated dates.F13: updated dates.F10 continued: international medical device regulators forum (imdrf) adverse event reporting health effect impact code: 4648 insufficient information; component code: 4755 part/component/sub-assembly term not applicable.On 28-feb-2020, a device history record(dhr) review was performed under (b)(4), the dhr review confirmed the endoscope was manufactured on 06-mar-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 08-mar-2017.After completion of all repairs, the scope was shipped back to the user on 24-mar-2020 under reference delivery # (b)(4).Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.

• 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: 9753427
• Report Number: 2518897-2020-00051
• Device Sequence Number: 11309034
• Product Code: EOQ
• UDI-Device Identifier: 04961333182268
• UDI-Public: 04961333182268
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2023
• Report Date (Section F): 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EB-1975K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/30/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/11/2023
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 04/11/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability; Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/11/2023