MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO CYSTOSCOPE 2.0C 5.5TP 400L

Model Number ECY-150S

Device Problem Device Contaminated at the User Facility (4064)

Patient Problem Drug Resistant Bacterial Infection (4553)

Event Date 10/22/2021

Event Type  Injury  

Event Description

Although the direct cause is unknown, there was a report that a hospitalization case occurred after using our scope.The customer contacted us as part of the investigation of the cause at the customer.At this time, there are no voices blaming ourselves products.Time series leading to hospitalization early (b)(6) 2021, to use our scope for inspection.On (b)(6) 2021 hospitalized due to infectious disease (infectious disease name: esbl-producing bacteria).Discharged on (b)(6) 2021.This event occurred at the time of after use.

Manufacturer Narrative

This device is not distributed in the usa, therefore the pma/510(k) number is not applicable.If additional information becomes available, a supplemental report will be filed with the new information.

Manufacturer Narrative

Evaluation summary: a patient who had undergone a procedure using the product on (b)(6), 2021 returned to the hospital on (b)(6), 2021 complaining of feeling unwell.He had been symptomatic for a few days prior to the return visit, but the details of his symptoms were unknown.The patient was diagnosed with an infection caused by esbl-producing bacteria and hospitalized.The medical institution could not rule out the possibility of infection via the product, so they reported the incident to pentax and requested retraining in cleaning and disinfection methods.As a result of interviews with the medical institution, the product in question was not cleaned and disinfected in accordance with the ifu.The medical institution was requested to return the product in question to investigate the route of infection, but this did not materialize.A sales representative visited the medical institution and confirmed that there were no visible abnormalities in the product's appearance and that it passed the leak test.Based on the results of these investigations, it could not be determined that the infection was caused by the product in question.Although the possibility that the product in question was involved in the infection cannot be completely ruled out, it may be related to the fact that cleaning and disinfection were not performed in accordance with the ifu.Correction information: g6: follow up #1.H6: coding changed based on the investigation result.Additional information: h4: device manufacture date.

• Brand Name: PENTAX
• Type of Device: VIDEO CYSTOSCOPE 2.0C 5.5TP 400L
• 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 ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 12872876
• MDR Text Key: 285066732
• Report Number: 9610877-2021-01661
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/11/2022

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: ECY-150S
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2021
• Initial Date FDA Received: 11/24/2021
• Supplement Dates Manufacturer Received: 11/12/2021
• Supplement Dates FDA Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/27/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization