MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ULTRASONIC GASTROVIDEOSCOPE

Model Number	GF-UC140P-AL5
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
It is reported in the literature titled "risk of infection transmission in curvilinear array echoendoscopes: results of a prospective processing and culture registry", 22/540 cultures of linear endoscopic ultrasound (eus) (4,2%) were positive for gram-negative bacilli after cleaning and high level disinfection (hld).Beginning in february 2015 to february 2016, curvilinear array (cla) echoendoscopes at a single tertiary care center underwent prospective bacterial surveillance cultures after reprocessing.Any growth of gram-negative bacilli was considered to be critical.Echoendoscopes with a positive result underwent quarantine followed by repeat disinfection and culture.During the study period, 540 cultures were obtained; 521 (96.5%) were primary cultures obtained from 18 cla echoendoscopes.Twenty-two primary cultures (4.2%) were positive for gram-negative bacilli after high-level disinfection reprocessing.Eleven different bacteria were isolated: klebsiella pneumoniae, citrobacter freundii, escherichia coli, pseudomonas aeruginosa, klebsiella oxytoca, sphingomonas paucimobilis, acinetobacter baumanii, enterobacter cloacae, hafnia alvei, pseudomonas putida, and stenotrophomonas maltophilia.Antibiotic sensitivity data on 19 of 24 bacteria (79.2%) isolated from positive primary cultures revealed no documented cases of carbapenem resistant enterobacteriaceae, cephalosporin-resistant-klebsiella, or multidrug-resistant acinetobacter.There have been no documented cases of patient-to-patient transmission.Conclusions: after following standard high-level disinfection and reprocessing, cla echoendoscopes can remain culture positive for high-concern organisms.Recommendations regarding infection risk should take into consideration elevator-containing echoendoscopes in addition to duodenoscopes to ensure patient safety and endoscope reprocessing efficacy.Case with patient identifier (b)(6) reports gf-uc140p-al5 scopes testing positive after hld, case with patient identifier (b)(6) reports gf-uct 180 scopes testing positive after hld, and case with patient identifier (b)(6) reports gf-uct140 scopes testing positive after hld.
Additional Manufacturer Narrative
This report is being updated to report investigation findings.New information is reported.The device history record (dhr) for the complaint device could not be reviewed as the serial number was not provided.Olympus does not ship any devices that to not meet all design and safety specifications.No device malfunction was reported in the literature/study.There were no human subjects in this study.The purpose of the study was evaluate reprocessing of this type scopes and make recommendations for surveillance procedures after reprocessing to ensure adequate reprocessing.

• Brand Name: ULTRASONIC GASTROVIDEOSCOPE
• Common Device Name: ULTRASONIC GASTROVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11760617
• Report Number: 8010047-2021-05747
• Device Sequence Number: 14346656
• Product Code: ODG
• UDI-Device Identifier: 04953170355448
• UDI-Public: 04953170355448
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K011314
• 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): 07/22/2021

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: GF-UC140P-AL5
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 05/03/2021
• Supplement Report FDA Received Date: 07/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1