MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; HDVIDEO COLONOSCOPE 3.8C 13.2T 1700L FWJ

Model Number	EC-3890LI
Medical Device Problem Code	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
Evaluation summary: it was caused due to excess force on the nozzle.We received the defect and conducted the following investigation and repair.Observations: bending rubber discolored, side body cover malfunction, jet socket missing, bending rubber cracked, bending rubber cracked, air/water nozzle missing.Repair.Replaced the bending rubber,side body cover, jet socket, air/water nozzle.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."air/water nozzle missing.- water jet channel missing metal piece came off.The issue occurred when disconnecting the scope from the block in the medivators.A radial jaw was used during the procedure.No medical intervention was needed (the issue occurred after the procedure)".Not known for the exact date, we just know the year the complaint was sent in to manufacturer.

• Brand Name: PENTAX
• Common Device Name: HDVIDEO COLONOSCOPE 3.8C 13.2T 1700L FWJ
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• MDR Report Key: 12230346
• Report Number: 9610877-2021-10203
• Device Sequence Number: 3802644
• Product Code: FDF
• UDI-Device Identifier: 04961333248148
• UDI-Public: 04961333248148
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/27/2021

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1