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

Model Number EB-1570K

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Fungal Infection (2419)

Event Date 08/20/2020

Event Type  Injury  

Event Description

Pentax medical was made aware of an event through a return materials authorization request involving pentax medical video bronchoscope model eb-1570k, serial number (b)(4) to be evaluated because it could possibly have caused patients to be infected.The user facility wants it to be checked out completely to verify.The user facility representative for (b)(6) hospital ((b)(6)), responded to good faith efforts(gfe) via email on (b)(6) 2021 and provided case information for two(2) patient cases.A unique mycobacterium (mycobacterium abscessus) was identified in two sequential bronchoscopy cases - all in patients who did not have any radiographic evidence for mycobacterium disease and were asymptomatic - and in each case, the same bronchoscope was used (the scope in question).Both patients have similar strain.Pentax medical video bronchoscope model eb-1570k, serial number (b)(4) has been used on six(6) total patients up until (b)(6) 2020.The facility confirmed they have seven(7) bronchoscopes onsite.Data on date of bronchoscopies and all cultures: (b)(6) 2020: mycobacterium abscessus, (b)(6) 2020: mycobacterium abscessus.The customer owned endoscope has not been received for evaluation or testing as of (b)(6) 2021.Eb-1570k, serial number (b)(4) has been routinely serviced at a pentax facility since the device was put into service.The investigation is in-process.This event meets the requirements for fda reportability; however submission of this report does not constitute an admission that medical personnel, user facility, importer, manufacturer or product caused or contributed to the event.

Manufacturer Narrative

Correction information: f7: follow up #1, f10: changed medical device problem code to : 2993 adverse event without identified device or use problem.F9: age of device.Evaluation summary: as a result of the investigation, it was found that the bacteria causing the infection were not detected from the endoscope.Therefore, we concluded that there is no causal relationship between the endoscope and the patient's infection.

• Brand Name: PENTAX
• Type of Device: 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: 12321960
• MDR Text Key: 267259283
• Report Number: 2518897-2021-00405
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/18/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: EB-1570K
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/18/2022
• Distributor Facility Aware Date: 07/14/2021
• Device Age: 151 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/18/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Race: White