MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II DUODENOVIDEOSCOPE

Model Number TJF-Q180V

Device Problem Device Reprocessing Problem (1091)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.An olympus endoscopy support specialist (ess) visited the user facility on february 19, 2019 to provide a scope reprocessing in-service to the staff.The ess reported they are using an automated endoscope reprocessor (aer) to reprocess their endoscopes.The customer is using a ¿hedgehog¿ a non-olympus cleaning brushes.The staff do not perform suction during manual cleaning, as they have no suction in the reprocessing room.The ess trained the main technician about the correct order of brushing of channels based on the recommended steps in the instructions for use.The ess reported that the bedside cleaning is being done properly.The ess also trained the staff about the process of performing channel checks prior to procedure.The ess provided the part number of the olympus cleaning and compatible endotherapy devices.The cause of the user¿s experience cannot be conclusively determined but the use of a non-olympus cleaning brushes cannot be ruled out as a contributory factor.

Event Description

Olympus was informed that a stent remained stuck inside the channel of the scope following procedure.The scope was reprocessed but was never retrieved.The stent came out of the scope and fell into a patient during a second procedure.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the user facility and the device evaluation results.As part of our investigation, olympus followed up with the user facility to obtain additional information regarding the reported event.The user facility further reported that the event occurred during an ercp with stone removal procedure.Unspecified endotherapy devices (dreamtome and tapertome) were used with the scope during the procedure.There was no patient infection reported.The model of the stent was a boston scientific pigtail pancreatic stent spsof-4-4.There was no missing component from the scope were observed.An endotherapy device was not used to inspect the channel prior to the procedure.Regarding the reprocessing: pre-cleaning is being performed immediately after procedure utilizing the manufacturer¿s instructions.The user facility wrote competencies based on instruction manuals.Prior to manual cleaning, the scope is being leak tested.During manual cleaning, the endoscope channel is being brushed with a single use endochoice hedgehog or olympus single use combination brush.The user facility utilizes a medivator edge automated endoscope reprocessor (aer) and rapicide for disinfectant solution.The minimum effective concentration is checked every use.There are no problems noted with the aer which was last maintenance on november, 2018.The user facility currently has on-site personnel from stryker endoscopy.All reprocessing personnel are properly trained to reprocess an endoscope as all competencies are completed prior to working in scope room.The endoscope is being stored hanging in cabinet.The scope was returned to olympus for evaluation.The service group's evaluation found the scope failed the leak test at the seam of the distal end cover/body.The distal end cover was noted to have dents and scratches.The bending section cover glue at the insertion tube side was noted to be cracked.There are multiple buckles found near the 60cm mark of the insertion tube.In addition, an inspection of the instrument channel noted scrape marks on the channel wall.There was no stent fragment or foreign material or stain noted inside the instrument channel.The scope was repaired and returned to the user facility.A review of the instrument history indicates the scope was purchased on (b)(6) 2011 and was last repaired on february 22, 2019.The cause of the reported event cannot be determined.However, based on the evaluation findings, improper maintenance/handling to the insertion tube/channel cannot be ruled out as a contributory factory to the multiple kinks on the insertion tube and scrape marks inside the instrument channel.As a preventive measure, the instruction manual provides warning to mitigate the risk of device damage which states, the instruction manual for use provides several warning and caution statements in an effort to prevent patient injury."do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient.¿.

• Brand Name: EVIS EXERA II DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 8380730
• MDR Text Key: 139679792
• Report Number: 2951238-2019-00478
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170229503
• UDI-Public: 04953170229503
• Combination Product (y/n): N
• PMA/PMN Number: K143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-Q180V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/31/2019
• Initial Date FDA Received: 02/28/2019
• Supplement Dates Manufacturer Received: 02/22/2019
• Supplement Dates FDA Received: 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1