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

Model Number TJF-Q190V

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Perforation (2001)

Event Date 10/24/2019

Event Type  Injury  

Manufacturer Narrative

The subject device in this report has not been returned to omsc for evaluation.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 the user facility aborted an endoscopic cholangiogastrostomy since esophagus in the upper third of the patient was perforated using the subject device.The perforation was small and treated with a clip during the procedure.Then the patient was transferred to the intensive cardiological care unit then was discharged now.The intended procedure will be performed at a later time.The physician at the user facility commented that the forceps elevator might have been in the lower position but there was no certainly in the procedure.The facility discontinued to use the subject device.

Manufacturer Narrative

This supplemental report is being submitted to provide the evaluation result of the device.The olympus france.(ofr) staff visited the user facility and confirmed the following; the user facility provided the following hypothesis; a deformation of the single use distal cover could become traumatic.The patient's mucous membrane could be traumatized by the forceps elevator.No abnormality in the subject device was confirmed.Olympus medical systems corp.(omsc) reviewed the manufacture history (dhr) of the device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device has not been returned to omsc but was returned to olympus europa se & co.Kg.(oekg).Oekg checked the subject device, especially the exterior and behavior of the forceps elevator of the subject device, and found that there were no abnormalities that could cause the reported event.The exact cause of the reported event could not be conclusively determined.

Manufacturer Narrative

This supplemental report is being submitted to additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.Omsc checked the subject device, especially the exterior of the forceps elevator of the subject device, and found that there were no abnormalities that could cause the reported event.The exact cause of the reported event could not be conclusively determined.However, the adverse events that occurred may have occurred due to facility handling.The instruction manual of the subject device already instructs; never insert or withdraw the endoscope under any of the following conditions.Patient injury, bleeding, and/or perforation can result.Insertion or withdrawal while the forceps elevator is raised.

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 10th, 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 the user facility aborted an endoscopic cholangiolithotomy since the esophagus in the upper third of the patient was perforated using the subject device.The perforation was small and treated with a clip during the procedure.Then the patient was transferred to the intensive cardiological care unit and was thereafter discharged.The physician at the user facility commented that the forceps elevator might have been in the lower position but he was not certain about the exact position.The facility discontinued use of the subject device.Olympus staff visited the user facility and confirmed the following; - no abnormality in the subject device was found by the olympus staff after inspecting the device and as discussed below the device was sent to olympus for further inspection.Olympus followed up with the user facility and obtained the following additional information on june 11th, 2020.Intended procedure was biliary tract calculus ablation and the ercp was not aborted but completed.Tracheal tube was used for this patient as almost all ercps in france are done with general anesthesia and tracheal tube.The perforation was found during the gastroscopy procedure for biopsy which was originally scheduled to be conducted just after the ercp.It is unknown when the perforation occurred during the ercp.Root cause analysis.The subject device was returned to olympus for evaluation, especially the exterior and functioning of the forceps elevator, and no abnormalities were found that could cause the reported event.Olympus also determined that the single use distal cover attached to the subject device could not be deformed even if an unexpected force was applied.The exact cause of the reported event cannot be conclusively determined at this time, however it is assumed the event was caused by following: -the tjf-q190v might have been inserted with the forceps elevator in the wrong position, and the protruding forceps elevator damaged the esophagus.-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.When the tjf-q190v with the forceps elevator in the wrong position was inserted into the pressed esophagus, the tjf-q190v damaged the esophagus. 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) units 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.Thus, the probability of occurrence of perforations which led to open surgery is 0.0006% (=1/170,200) resulting in the level ¿remote¿ (according to table 2) based on the above, olympus rates this event as ¿acceptable¿ (according to table 3).2.Perforation and laceration which did not lead to open surgery between august 1st, 2018 and june 19th, 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) units 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.Thus, probability of occurrence of laceration due to the forceps elevator is 0.0029% (=5/170,200) resulting in the level ¿occasional¿ (according to table 2) based on the above, olympus rates this event as ¿acceptable¿ (according to table 3).3.Damage of guide wire by forceps elevator.Between august 1st, 2018 and june 19th, 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) units 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.Thus, probability of occurrence of laceration due to the forceps elevator is 0.0012% (=2/170,200) resulting in the level ¿occasional¿ (according to table 2) based on the above, olympus rates this event as ¿acceptable¿ (according to table 3).4.The procedure was abandoned due to insufficient movement of forceps elevator between august 1st, 2018 and june 19th, 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.1,852 units 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.Thus, probability of occurrence of laceration due to the forceps elevator is 0.0006% (=1/170,200) resulting in the level ¿remote¿ (according to table 2) based on the above, olympus rates this event as ¿acceptable¿ (according to table 3).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: 9380485
• MDR Text Key: 184760980
• Report Number: 8010047-2019-04092
• 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: foreign,health professional,u
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/04/2019
• Initial Date FDA Received: 11/26/2019
• Supplement Dates Manufacturer Received: 12/09/2019; 01/02/2020; 02/12/2020; 06/11/2020
• Supplement Dates FDA Received: 12/25/2019; 01/21/2020; 03/04/2020; 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other