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

Model Number	EC-3890LI
Medical Device Problem Code	No Display/Image (1183)
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
If additional information becomes available, a supplemental report will be filed with the new information.
Event or Problem Description
Pentax medical became aware of a report for an event which occurred in the usa stating, "no video image/error message, scope not connecting" involving pentax model ec-3890li/serial (b)(4).Additional information from the user stated the event occurred during pre-inspection check.No further information was provided.The device was returned to pentax on 07/07/2021.Pentax service inspectional findings included: image intermittent, passed dry/wet leak tests, ccd circuit board loose center connection, #3 remote control button sticking.Repairs were performed on the device which included replacement of the following components: o-rings and seals, remote control button,pcb for ccd drive pb-free, electrical connector assy.The device has been routinely serviced by pentax since install.

• Brand Name: PENTAX
• Common Device Name: VIDEO COLONOSCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• MDR Report Key: 12240441
• Report Number: 9610877-2021-00287
• Device Sequence Number: 17084032
• Product Code: FDF
• UDI-Device Identifier: 04961333232345
• UDI-Public: 04961333232345
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K131855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/28/2021

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: EC-3890LI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1