MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM VIDEO ENDOSCOPE EC-760R-V/L; COLONOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	EC-760R-V/L
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On august 8, 2023, fujifilm healthcare americas corporation was informed of an event involving ec-760r-v/l.It was reported that customer requested advice on a potential infection control issue.They had an inexperienced scope tech put ¼ - 1/2 cup of empower enzymatic solution into one of their medivators dsd washers where the opa was supposed to go, and two of the scopes that were run through there were used on patients before they caught the mistake.There is no serious injury or death associated with the event.Therefore, this report is being submitted in abundance of caution.
Additional Manufacturer Narrative
A supplemental report will be submitted pending investigation results.
Additional Manufacturer Narrative
3001722928-2023-00050 and 3001722928-2023-00055 are identical report.The receipt of and acknowledgements to 3001722928-2023-00050 were not received.Since the submission of the report could not be confirmed, 3001722928-2023-00055 was submitted.3001722928-2023-00055 s2 is being submitted because 3001722928-2023-00055 s1 did not show that the additional narrative was saved and sent.
Additional Manufacturer Narrative
The manufacturer has no new information from the investigation of the incident.
Additional Manufacturer Narrative
This supplement is being submitted to fda as a result of fujifilm corporation's commitment to perform a retrospective review of all mdrs submitted between october 1, 2021 and october 12, 2023, due to fda 483 observations issued to fujifilm corporation on september 22, 2023.This supplement includes missing or incorrect information in the original mdr filing, and previous supplements where applicable.3001722928-2023-00055 s2 indicated that this is a combination product.This is an error.It is not a combination product.

• Brand Name: FUJIFILM VIDEO ENDOSCOPE EC-760R-V/L
• Common Device Name: COLONOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 25885 38; JA 2588538
• Manufacturer (Section G): FUJIFILM CORPORATION-FTYO; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• Manufacturer Contact: 700 konaka-cho; sano city, tochigi 327-0-00
• MDR Report Key: 17701856
• Report Number: 3001722928-2023-00055
• Device Sequence Number: 7521987
• Product Code: FDF
• UDI-Device Identifier: 14547410358688
• UDI-Public: (01)14547410358688(11)080401
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K172916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/08/2023

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-760R-V/L
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2023
• Supplement Date Received by Manufacturer: 08/08/2023; 08/08/2023; 08/08/2023; 08/08/2023
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 10/05/2023; 10/05/2023; 10/25/2023; 11/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown