MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. JF-140; DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	UNKNOWN
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
Event or Problem Description
Olympus received the following article on (b)(6) 2021 from the us/emea medtech newsletter: (b)(6) 2021 (9934 gastrointestinal endoscopy volume 93, no.4: 2021): enhanced reprocessing of duodenoscopes: a glass half full or half empty? gastrointestinal endoscopy sushrut sujan thiruvengadam, md v.Raman muthusamy, md, mas- (b)(6) 2021.The aim of this study was to compare the efficacy of reprocessing duodenoscopes with either double high-level disinfection (dhld) or liquid chemical sterilization (lcs).This was a prospective randomized study using 67 duodenoscopes (olympus models tjf-q180 (reported in case with patient identifier (b)(6)) and tjf-160 (reported in case with patient identifier (b)(6)) randomized, and 10 older-model duodenoscopes, olympus jf-130 (reported in case with patient identifier (b)(6)), jf-140 (reported in case with patient identifier (b)(6)), and tjf-140 (reported in case with patient identifier (b)(6)) which were included in this analysis but were not randomized.All older scopes were reprocessed with dhld, given the institutional experience with dhld on these less commonly used models.Duodenoscopes were randomly cultured after reprocessing.There was no patient involvement.The study concluded there was no significant difference in the positive culture results between the dhld group and the lcs group.
Additional Manufacturer Narrative
This report is being submitted to provide investigation findings.The device history record (dhr) for the complaint device could not be reviewed since the lot number was not provided.Olympus does not ship any device that does not meet all design and safety specifications.Conclusion: the definitive cause of the reported events could not be established.Based on the limited available information, it is presumed that the cause of the reported events is not related to the device.

• Brand Name: JF-140
• Common Device Name: DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11655250
• Report Number: 8010047-2021-04890
• Device Sequence Number: 3495589
• Product Code: FDT
• UDI-Device Identifier: 04953170339851
• UDI-Public: 04953170339851
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,literatur
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2021

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1