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

Model Number TJF-Q190V

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 12/03/2019

Event Type  Injury  

Manufacturer Narrative

The subject device in this report has not been returned to olympus medical systems corp.(omsc) for evaluation.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.There was no malfunction report of the subject device concerning the events.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that during replacement of an unspecified stent using the subject device, the user facility made a deep wound without perforation in the patient¿s esophageal.The deep esophageal wound was treated with an unspecified clip during the procedure and no bleeding was observed.The intended procedure was completed.There was no report of further patient injury with the event.The user facility alleged that the deep esophageal wound was due to the forceps elevator of the subject device.

Manufacturer Narrative

This supplemental report is being submitted to clarify the initial report and provide additional information.The clarification was made in reaction to the email from fda that olympus received on june 11th, 2020.Q1.Please provide the root cause(s) and risk analysis in these events.Olympus response: the subject events are associated with perforation of esophagus, laceration of esophagus, perforation of duodenal bulb, damage of guide wire by forceps elevator and suspected malfunction in the movement of the forceps elevator.The root cause analysis result and the risk analysis result are as follows; event description: olympus was informed that during replacement of an unspecified stent, the user facility made a deep wound without perforation in the patient¿s esophagus.The deep esophageal wound was treated with an unspecified clip during the procedure and no bleeding was then observed.The intended procedure was completed.There was no report of further patient injury with the event.The user facility alleged that the deep esophageal wound was due to the forceps elevator of the subject device.Olympus followed up with the user facility and olympus obtained the following additional information on june 11th, 2020.Tracheal tube was used for this patient as almost all ercps in france are done with general anesthesia and tracheal tube.The wound was found during the gastroscopy procedure for biopsy which was originally scheduled to be conducted just after the ercp.It is unknown when the wound occurred during the ercp.Olympus tried to obtain the information about the procedure such as the type of stent and endotherapy accessories which were used, but did not obtain it.Root cause analysis : olympus staff visited the user facility.There was no abnormality of the subject device.The exact cause of the reported event cannot be conclusively determined at this time, however it is assumed the event was caused by following: when the stent is retrieved, the stent is removed from the patient¿s body together with the duodenoscope.During the removal, the stent is held by endotherapy accessory such as grasping forceps that is come out from the distal end of the duodenoscope.During removal of the tjf-q190v from the patient's body while holding the stent with a grasping forceps, the stent or forceps contacted the esophagus and damaged the esophageal wall.Due to the expansion of the balloon at the distal end of the tracheal tube, the wall of the trachealis was compressed toward the esophagus.Since the tjf-q190v was removed while holding the stent with a grasping forceps, the stent or forceps damaged the esophagus.Risk assessment: olympus evaluated the current risk of reported complaints.The evaluation result is as follows; 1.Perforation and laceration which led to open surgery between (b)(6) 2018 and (b)(6) 2020, there have been a total of 2 complaints of perforation which led to open surgery.However, in 1 complaint, it was confirmed there was no irregularity of the subject device and based on the physician¿s comment the complaint can be considered as complication of the ercp procedure, therefore olympus has excluded this complaint from its risk assessment.Olympus evaluated the severity level of these events as ¿critical¿ (according to table1), because even though the medical intervention was conducted, this kind of injury may lead to a harm with a severity level seen as ¿critical¿.(b)(4)of these models (tjf-q190v and tjf-q290v) have been supplied worldwide.It is estimated that the devices have been used in about 170,200 procedures between august 1st, 2018 and june 19th, 2020.(b)(4).2.Perforation and laceration which did not lead to open surgery between (b)(6) 2018 and (b)(6) 2020, there have been a total of 5 complaints of perforation and laceration which did not lead to open surgery.Olympus evaluated the severity level of these events as ¿serious¿ (according to table1), because the event can be serious if bleeding from the perforation or laceration is not stopped.(b)(4) of these models (tjf-q190v and tjf-q290v) have been supplied worldwide.It is estimated that the devices have been used in about 170,200 procedures between august 1st, 2018 and june 19th, 2020.(b)(4).3.Damage of guide wire by forceps elevator between (b)(6) 2018 and (b)(6) 2020, there have been a total of 2 complaints of damage of guide wire by forceps elevator.Olympus evaluated the severity level of these events as ¿minor¿ (according to table1), because the guide wire exchange is necessary if the guide wire is damaged during the procedure.(b)(4) of these models (tjf-q190v and tjf-q290v) have been supplied worldwide.It is estimated that the devices have been used in about 170,200 procedures between (b)(6) 2018 and (b)(6) 2020.(b)(4).4.The procedure was abandoned due to insufficient movement of forceps elevator between (b)(6) 2018 and (b)(6) 2020, there have been a 1 complaint that the procedure was abandoned due to insufficient movement of forceps elevator.In this event, no patient injury was reported.Olympus evaluated the severity level of this event as ¿minor¿ (according to table1), because the procedure was abandoned.(b)(4)of these models (tjf-q190v and tjf-q290v) have been supplied worldwide.It is estimated that the devices have been used in about 170,200 procedures between (b)(6) 2018 and (b)(6) 2020.(b)(4).Q2.In your 510k submission, there were changes made to the elevator area of tjf-q190v.Please explain if these changes would contribute to the adverse events, in the case users getting used to the previous duodenoscope model.Olympus response: design changes: design changes made to the elevator area from previous duodenoscope model ¿tjf-q180v¿ and reported in the 510k are as follows; a.Removable distal cover intended for single use tjf-q190v has a removable single-use distal cover (maj-2315) instead of a fixed distal cover as the previous model tjf-q180v.B.Dlc coating.Diamond like carbon (dlc) coating was applied on the arm within the distal end for actuating the forceps elevator in tjf-q190v.The dlc coating keeps the smooth movement of the forceps elevator even after repeated use of tjf-q190v.C.Screw less assembling of the forceps elevator to the arm the shape of arm is changed and inserted to the forceps elevator.The tjf-q190v doesn¿t contain a screw to fixate the arm and forceps elevator.The arm is inserted to the elevator and the elevator is held in place on the arm by friction for the subject device.Evaluation result on whether the design change would contribute to the adverse events or not.Olympus has concluded that the design change b and c do not contribute to the adverse events because the design changes do not have any influence on the operation and the function and outer surface of the forceps elevator and the appearance of the distal end.Therefore, olympus evaluate the relationship between the design change a and each adverse event as follows; (1) perforation and laceration: olympus conducted the assessment whether the design change a made to the elevator area could have contributed to each adverse event.In the design change a, it was confirmed that the protruding length of the tjf-q190v is shorter than that of tjf-q180v when the forceps elevator raised at maximum position.And the forceps elevator of the tjf-q190v and the tjf-q180v both have a smooth surface with no edge.In addition, both the operation method of the forceps elevator and the labeling of the control section are the same between tjf-q190v and tjf-q180v.Both models are designed so that the forceps elevator can be stored inside the distal end of endoscope by moving the elevator control lever.Therefore, the design change a above made to the elevator area cannot contribute to each adverse event.(2) damage of guide wire by forceps elevator: in the design change a, the dimension of the forceps elevator has been slightly modified.However, both tjf-q190v and tjf-q180v have the same guide wire locking structure.In addition, it is confirmed that the guide wire locking force of tjf-q190v is equivalent to that of tjf-q180v, therefore it is considered there is no difference in the load applied to the guide wire.Also, when developing the tjf-q190v, olympus confirms that after locking the guide wire by maximally raising the forceps elevator of tjf-q190v, there was no breakage of outer surface such that the core wire was exposed on the guide wire.Therefore, the design change a above made to the elevator area cannot contribute to the event.(3) the procedure was abandoned because the forceps elevator did not respond as physician would expect.Olympus checked the subject device and found no irregularity of the subject device.The exact cause of the reported event and whether the design changes made to elevator contribute to the insufficient movement of forceps elevator cannot be conclusively determined at this time.Olympus concluds that the design change a, b and c did not contribute to the adverse events because the design change does not have any influence on the operation and the function of the forceps elevator.Q3.Please provide your mitigation strategies.Olympus response: (1) perforation and laceration.Based on the following instructions and precautions for the tjf-q190v, that are already in the operation manual, we believe the current manual provides appropriate and adequate guidance on this issue: never insert or withdraw the endoscope under any of the following conditions.Patient injury, bleeding, and/or perforation can result.While the bending section is locked in position.Insertion or withdrawal with excessive force.Insertion or withdrawal while the forceps elevator is raised.(refer to: tjf-q190v, operationmanual p.67, rc4994 03).Keep the elevator control lever moved all the way in the opposite direction of the ¿

• Brand Name: EVIS EXERA III DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9514400
• MDR Text Key: 185599949
• Report Number: 8010047-2019-04573
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TJF-Q190V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other