MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA III DUODENOVIDEOSCOPE

Model Number TJF-Q190V

Device Problem Device Reprocessing Problem (1091)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/27/2022

Event Type  Injury  

Event Description

The customer reported during a preventative maintenance inspection by an olympus endoscopy support specialist (ess) on the evis exera iii duodeonvideoscope, an endoscopic retrograde cholangiopancreatography (ercp) procedure was completed on (b)(6) 2022. During the procedure, debris from a previous ercp was "pushed out" into the patient during the procedure. Patient "a" had a stent removal where the stent was removed and pulled up through the endoscope channel, part of the stent became lodged in the endoscope. The endoscope was cleaned and on (b)(6) 2022, the device was reused on patient "b" where part of the stent from patient "a" was introduced to patient "b. " the endoscope was reprocessed and pulled from use, and an internal investigation has begun at the hospital. The customer reported the debris was removed from the patient with a snare. The patient experienced no adverse effects as a result of this occurrence. It was reported the patient required an exposure panel (blood draw) which was negative. The patient's current condition is described as discharged home from the outpatient procedure.

Manufacturer Narrative

The device referenced in this report has been evaluated by the olympus ess. Preliminary findings are reported. Physical evaluation of the device found the bending section glue was peeling and scrape marks were identified on the insertion tube. The olympus ess noted during the inspection the customer is using the bw-412t cleaning brushes, scope buddy plus is used for aspiration and automated flushing, medivator advantage is used for automated reprocessing, and resi test is being completed on all endoscopes, following manual cleaning. Recommendations were made by ess to customer to schedule device training as well as a reprocessing in-service to ensure all staff members are properly trained. This report will be updated upon completion of the investigation or upon receipt of additional relevant information. This event has been reported by the importer on mdr # 2429304 - 2022 - 00040.

• Brand Name: EVIS EXERA III DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15298653
• MDR Text Key: 298666917
• Report Number: 9610595-2022-01330
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170452024
• UDI-Public: 04953170452024
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: TJF-Q190V
• Device Catalogue Number: N5992941
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 08/25/2022 Patient Sequence Number: 1