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.

Event Description

Additional information received via medwatch report: during the (b)(6) 2022 ercp procedure, post sphincterotomy and scope insertion, the broken piece of stent was pushed out into the patient's stomach.The piece of stent was immediately retrieved with a snare.

Manufacturer Narrative

This supplemental report is being submitted to provide a correction to b3.

Manufacturer Narrative

This report is being updated to report additional information reported by the customer and investigation findings.New information is reported in h6, and h10.Since the subject device was not sent to olympus, there was no device inspection result.According to the endoscopic support specialist who examined the device onsite, there was peeling of the adhesive rubber glue and scape marks on the insertion tube.Repair history review: the subject device has not been repaired within the past one year.The device history record (dhr) for the reported serial number was reviewed.It is confirmed that the device met all design and safety specification when it was shipped.The instructions for use shipped with the device provides the user with the following information related to the reported event: 4.1 precautions: do not retrieve the stent through the instrument channel of the endoscope.A stent or piece(s) of a stent may stay in the instrument channel or the suction channel of the endoscope even after reprocessing.It may cause incomplete reprocessing, and pose an infection control risk, cause equipment damage, or reduce performance.Operation manual: 3.8 inspection of the endoscopic system: inspection of the instrument channel and forceps elevator: 3 insert the endotherapy accessory through the biopsy valve.Confirm that the endotherapy accessory extends smoothly from the distal end of the endoscope.Also, make sure that no foreign objects come out of the distal end of the endoscope.1.4 precautions: all channels of the endoscope, including the instrument channel, and all accessories used with the endoscope during the patient procedure, such as all valves, must be reprocessed after each patient procedure, even if the channels or accessories were not used during the patient procedure.Insufficient reprocessing of these components may pose an infection control risk to patients and/or operators.[conclusion root cause of the suggested event was not specified.Consideration according to investigation findings, we presumed that the suggested event occurred by the following mechanism.I) when the user retrieved the stent through biopsy channel during previous ercp, a part of the stent got caught in the channel and remained there.Ii) since user¿s reprocessing was different from ifu recommendation, the stent caught in the channel was not removed.Iii) the presence of the stent inside the channel could not be detected due to inadequate inspection prior to use.The stent caught in the biopsy channel could have been detected during inspection prior to use since ifu (operation manual) states as follows: operation manual: 3.8 inspection of the endoscopic system: inspection of the instrument channel and forceps elevator: 3 insert the endotherapy accessory through the biopsy valve.Confirm that the endotherapy accessory extends smoothly from the distal end of the endoscope.Also, make sure that no foreign objects come out of the distal end of the endoscope.Moreover, ifu (reprocessing manual) states as follows: 1.4 precautions: all channels of the endoscope, including the instrument channel, and all accessories used with the endoscope during the patient procedure, such as all valves, must be reprocessed after each patient procedure, even if the channels or accessories were not used during the patient procedure.Insufficient reprocessing of these components may pose an infection control risk to patients and/or operators.

• 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: Nurse
• 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: Health Professional
• 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 Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 17 YR
• Patient Sex: Female
• Patient Weight: 50 KG