MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM; COLONOSCOPE

Model Number	EC-600HL
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause of the clog in the outlet of the water jet channel was determined to be white lint.This white lint likely originated from a cloth or gauze used to wipe the distal end of the device before the subject procedure.Therefore, the user would have failed to properly inspect the endoscope channels before use, as instructed in the labeling.Further investigation is ongoing to determine when the clog occurred.Since it is not certain that the lint was introduced between procedures and not during a previous procedure, this incident is being reported in an abundance of caution.There is no report of patient infection.
Event or Problem Description
Something appears to be lodged in the forward water jet of the endoscope forcing a bifurcated stream of water instead of one continual stream.Doctor was unsure if the bifurcated stream was apparent prior to the case, or happened intraprocedural.If prior to the case, then this could be a cross contamination issue.
Event or Problem Description
Something appears to be lodged in the forward water jet of the endoscope forcing a bifurcated stream of water instead of one continual stream.Doctor was unsure if the bifurcated stream was apparent prior to the case, or happened interprocedurally.If prior to the case, then this could be a cross contamination issue.
Additional Manufacturer Narrative
Additional information: it was indicated that there was mucosal and superficial abrasion, however it did not result in any non-routine action or treatment.There was no patient serious injury reported.Initial mdr aware date was left blank but should have been 11 jul 2018; new follow up aware date listed in this report is for the latest information update.Codes updated.Further investigation was conducted however there was no new information available.If any additional information is provided, a supplemental report will be submitted.: the cause of the clog in the outlet of the water jet channel was determined to be white lint.This white lint likely originated from a cloth or gauze used to wipe the distal end of the device before the subject procedure.Therefore, the user would have failed to properly inspect the endoscope channels before use, as instructed in the labeling.Further investigation is ongoing to determine when the clog occurred.Since it is not certain that the lint was introduced between procedures and not during a previous procedure, this incident is being reported in an abundance of caution.There is no report of patient infection.

• Brand Name: FUJIFILM
• Common Device Name: COLONOSCOPE
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• MDR Report Key: 7762697
• Report Number: 3001722928-2018-00057
• Device Sequence Number: 13901678
• Product Code: FDF
• UDI-Device Identifier: 04547410330212
• UDI-Public: (01)04547410330212(11)170301
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K180405
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2018

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-600HL
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 08/08/2018
• Supplement Report FDA Received Date: 08/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1