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

Model Number	EB-1570K
Medical Device Problem Codes	Device Reprocessing Problem (1091); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility response to a good faith effort(gfe) was provided via e-mail on aug 4 2021.Thirteen devices were involved in this contamination event, with no patient involvement.The type of pollution was found to be dirt / sediment from well water.They could see the dirt in the water, no scopes were processed in dirty water.The dirt ran through the water system and that took care of the problem.We confirmed that the hospital was cleaning the scopes according to the instructions for use, but could not clean due to dirty water.Also, this event occurs only one day and does not occur repeatedly.Evaluation summary: it was caused due to incorrect reprocessing by the customer.In addition, we confirmed that the insertion flexible tube crush; however, it is not related to the alleged complaint.Related mdr:9610877-2021-10449,9610877-2021-10450,9610877-2021-10451,9610877-2021-10452,9610877-2021-10465,9610877-2021-10466,9610877-2021-10467, 9610877-2021-10468,9610877-2021-10469,9610877-2021-10470,9610877-2021-10471,9610877-2021-10472.This report is being filed as part of the pentax backlog management plan.
Event or Problem Description
This event occurred during reprocessing.There was no report of patient harm.Potential endoscope contamination.(b)(6) 2021 today we had issue without water which caused our scopes to either no get cleaned after procedure or they were cleaned with dirty water.Not known for the exact date, we just know the year the complaint was sent in to manufacturer.

• 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: 12322709
• Report Number: 9610877-2021-10464
• Device Sequence Number: 4980928
• Product Code: EOQ
• UDI-Device Identifier: 04961333228102
• UDI-Public: 04961333228102
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K131028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/16/2021

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: EB-1570K
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 08/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1