MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM ENDOSCOPE EC-760R-V/L

Model Number	EC-760R-V/L
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	08/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject scope was returned to fmsu and inspected; inspection did not reveal any deficiencies.Insertion tube flexibility was found to be within specification and there was no sharpness found on the distal tip of the scope.The customer indicated that the scope was used with a third party stiffening wire which was inserted into the biopsy channel during the procedure; this would further stiffen the insertion section.The use of this additional accessory, along with a technician applying pressure may have contributed to causing the mucosal abrasion/tear.If any additional relevant information is provided, a supplemental report will be submitted.
Event or Problem Description
On (b)(6) 2019 fujifilm corporation was informed that a polypectomy procedure with a fujifilm endoscope resulted in a mucosal abrasion/tear.The in-room technician indicated that the physician was using the number 3 setting on the fam along with a third party stiffening wire (stiffest model) while the technician was applying pressure.The physician said that the patient was being treated for polyps and there was slight trauma to the colon in which the physician believed was endoscopic scope trauma; a tear that was approximately 1.5 cm long.The physician and his medical staff believe it was caused by the ridges of the tip of the scope.It was confirmed that there were no serious injuries and the physician completed the procedure with the same scope; the tear was treated with clips.Afterwards, the patient was sent for a ct scan as a safety precaution; the results were normal.The physician confirmed that the patient is fine, the patient was not hospitalized and did not need additional medical attention.The physician was unsure how many other patients received treatment with the same scope, however, there were no similar reports or patient injury related to this scope.The physician confirmed that the scope was taken out of use and was saved for the sales representative to be sent for evaluation; scope was sent to fujifilm medical systems u.S.A., inc (fmsu) for inspection.There was no serious injury or death associated with this event; this report is being submitted in abundance of caution.

• Brand Name: FUJIFILM ENDOSCOPE EC-760R-V/L
• Common Device Name: FUJIFILM ENDOSCOPE
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun; kanagawa, 00258 8538; JA 002588538
• MDR Report Key: 9041862
• Report Number: 3001722928-2019-00011
• Device Sequence Number: 19305726
• Product Code: FDS
• UDI-Device Identifier: 14547410358688
• UDI-Public: (01)14547410358688(11)190401
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K172916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: EC-760R-V/L
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention