MAUDE Adverse Event Report: FUJIFILM CORPORATION HIGH DEFINITION DIGITAL VIDEO ENDOSCOPE, COLONOSCOPE; FLEXIBLE VIDEO ENDOSCOPE

Model Number	EC-530LS2
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
In response to the fda inspection conducted in (b)(4) 2015, a phase 1 two year retrospective review ((b)(4) 2013 to (b)(4) 2015) ) of all endoscope service work orders was performed in order to identify and assess endoscope malfunctions that may potentially fall within the mdr reportability regulations 21 cfr 803.As a result of that initial phase 1 retrospective review, mdrs were submitted retrospectively.A phase 2 retrospective review for the period of (b)(4) 2015 to (b)(4) 2016, has also been conducted.As a result of the phase 2 review, it was determined that the identified malfunction may trigger, in a worst case scenario the "insertion portion suddenly becomes stiff during the procedure and detected during procedure".However, because there is limited information regarding the underlying event which led to the repair, the company is unable to determine whether the worst case scenario actually occurred and caused any risk to a patient.No known patient injury or death resulted from this event; this mdr is being submitted in an abundance of caution.

• Brand Name: HIGH DEFINITION DIGITAL VIDEO ENDOSCOPE, COLONOSCOPE
• Common Device Name: FLEXIBLE VIDEO ENDOSCOPE
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• MDR Report Key: 7211608
• Report Number: 3001722928-2018-00038
• Device Sequence Number: 16173642
• Product Code: FDF
• UDI-Device Identifier: 04547410323863
• UDI-Public: 04547410323863
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K112391
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/23/2018

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: Physician
• Device Model Number: EC-530LS2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2015
• Initial Report FDA Received Date: 01/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1