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 Unspecified Tissue Injury (4559)

Event Date 08/19/2021

Event Type  malfunction  

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation and the investigation is in process.Maj-2315, it is unknown if lot h0605 or h0305 was involved in this event.The olympus endoscopy support specialist (ess) confirmed the in-service for the tjf-q190v duodenovideoscopes (reprocessing and customer competency) was successfully completed when the facility received the scope in 02jun2021.On 24aug2021,after the reported event, the ess, along with endotherapy territory manager and clinical endotherapy clinical specialist, observed the facility's lead technician successfully demonstrate attaching and removing the disposable cap on the distal end of the scope.On 07sep2021, the endotherapy clinical specialist observed the doctor's next case and did not observe any issues or incorrect use of the scope and cap.The lead technician stated it is the doctor's standard practice to remove non-olympus stents through the scope channel.He also stated the doctor's patient population consists of more complex and difficult cases, sometimes with altered anatomy.At times, when the doctor is removing the stent through the scope, the bending section is retroflexed because of the patients' abnormal anatomy.The lead technician stated it is possible this may be a contributing factor of the cap issues recently experienced.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

Two different events ((b)(6) 2021 and (b)(6) 2021) were reported where there was human tissue found in the evis exera iii duodenovideoscope forceps elevator after the procedures were completed, before sending the scope to reprocessing.The physician was performing a therapeutic endoscopic retrograde cholangiopancreatography for both events.In both events, the human tissue was found after the patient had left the procedural room and in the recovery unit.The doctor confirmed no post surgical complications and no bleeding was experienced by the patients involved with these two events.It was confirmed the physician was using the correct technique when using and removing the scope.The lead technician confirmed the cap was correctly applied to the distal end of the scope.No additional information is available for the july 2021 event.The physician's and lead technician's opinion is the events are attributed to a cap issue.In (b)(6), at the end of the procedure, human tissue was observed in the forceps elevator after pulling a non-olympus 7 or 10 french plastic stent forcefully through the scope channel.The human tissue was approximately 2 centimeters long.In addition, at the end of the procedure, the cap was found to be split and come off the scope easily.There are 4 complaints involved to capture the two patient events as follows: (b)(6) event: (b)(6) is for the scope, tjf-q190v; (b)(6) is for the cap, maj-2315.(b)(6) event: (b)(6) is for the scope, tjf-q190v;c21343296 is for the cap, maj-2315.This is complaint 1 of 4.This report is for patient identifier (b)(6) for the scope event in (b)(6) 2021.

Manufacturer Narrative

This supplemental report is being sent to provide additional information provided by the customer.The following fields have been updated: although the customer initially reported the device was available for return, it is no longer available to be returned.The device will not be returned.

Event Description

The customer provided additional information: the customer clarified human tissue was lodged between the elevator and the cap.The tissue was not sent for examination or further testing and the customer is unable to determine where the human tissue may have originated from.The suction pressure used in the procedure is unknown.The device is no longer available for return.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer¿s investigation and the results of the device history records (dhr) review.The dhr for this device were reviewed and all records indicated the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.A definitive root cause was not identified.Based on the available information, the legal manufacturer determined the probable cause of the failure is undetermined.The user could have prevented the event if the user handled the scope in accordance with the following ifu (operation manual): important information please read before use: examples of inappropriate handling: applying suction with the distal end of the endoscope in prolonged contact with the mucosal surface, with higher suction pressure than required, or with prolonged suction time may cause bleeding and/or lesions.3.5 attaching accessories to the endoscope: attaching the single use distal cover: never use a single use distal cover with cracks or pinholes.Replace it with a new one.If a single use distal cover with cracks or pinholes is used, it could fall off during the examination and/or, it may cause thermal injury due to electric current leaks from cracks or pinholes when high-frequency cauterization treatment is performed.Also, using the single use distal cover with cracks may cause patient injury due to sharp edges.Correction and preventative action (capa) investigation has been opened to further investigate this issue.

• 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: 12460775
• MDR Text Key: 281955741
• Report Number: 8010047-2021-11627
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170405563
• UDI-Public: 04953170405563
• Combination Product (y/n): N
• PMA/PMN Number: K202661
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1292-2021
• Patient Sequence Number: 1
• Treatment: MAJ-2315