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

Model Number TJF-Q190V

Device Problem Material Separation (1562)

Patient Problems Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/29/2021

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.Correction and preventative action (capa) investigation has been opened to further investigate this issue.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported during an endoscopic retrograde cholangiopancreatography (ercp) using an evis exera iii duodenovideoscope, the single use disposable cap was found to be missing from the end of the scope upon scope withdrawal.The physician went back in with another scope to find and retrieve the distal cap but couldn't find it at first.The physician then used a glide scope and was able to locate and retrieve the distal cap.No mucosal bleeding was found in the stomach when they went back in.Upon inspection of the distal cap after retrieval, it was found to have a tear that left a sharp edge.It is reported the physician does routinely use suction upon withdrawal of the scope from the stomach and esophagus.The customer confirmed there was no injury to the patient as a result of this occurrence.The patient's current condition is reported as stable/ discharged.The distal cap cannot be returned to olympus for physical evaluation.

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.New information is reported in b5, h6, and h10.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.The following information provided to customers is in the instructions for use: ¿important information ¿ please read before use: precautions: never use the endoscope unless the single use distal cover is properly attached to the distal end.If the single use distal cover is not attached properly, it may slip off or fall off the distal end during the examination.This could result in thermal injury when the endoscope is used with high-frequency endotherapy accessories.Also, continuing the examination with the single use distal cover off may cause patient injury by the uncovered distal end of the endoscope.In addition, if the single use distal cover falls off in the oral cavity, it may cause aspiration or respiratory distress if not promptly identified and removed.3.4 inspection of accessories: inspection of the single use distal cover (maj-2315): should any irregularity be observed when inspecting the single use distal cover, do not use it.A single use distal cover with irregularity could not serve the endoscope properly and/or could fall off during the examination.Using the endoscope without the single use distal cover could cause patient injury and this could result in thermal injury when the endoscope is used with high-frequency endotherapy accessories.In addition, if the single use distal cover falls off in the oral cavity, it may cause aspiration or respiratory distress if not promptly identified and removed.¿ a definitive root cause was not identified.Based on the available information, the legal manufacturer determined the probable cause of the failure is likely due to the cover being damaged when attaching it to the scope by pushing it diagonally, therefore it being easy for it to come off the scope during use.

Event Description

Update: case with patient identifier (b)(6) reports the disposable cap used in this procedure.

Manufacturer Narrative

This supplemental report is being submitted to correct the following sections of the medwatch form section b1, b2, h6, and h1.In addition, based on further review of the audio call from the independent sales representative, the report has already been classified as an adverse event due to the injury sustained by the patient during the procedure.In addition, it was reported that an esophagogastroduodenoscopy (egd) scope (model/serial number unknown) was used to reexamine the patient's stomach and duodenum in an attempt to locate the missing distal cap; however, the distal cap was not located.The anesthesiologist then utilized a glide scope (model/serial number unknown) and the distal cap was located in the oropharynx.They found some bleeding at the back of the mouth.They noticed that the distal cap was split or torn with a little bit of blood on it.The user was not sure if the distal cap was damaged during the retrieval or damaged prior to the procedure.According to the original reporter (independent sales representative) the most likely cause of the reported phenomenon was due to the improper attachment of the cap to the distal end.The customer was provided retraining on how to properly attach the cap to the distal end.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12198216
• MDR Text Key: 274495304
• Report Number: 8010047-2021-09133
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170405563
• UDI-Public: 04953170405563
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202661
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 02/17/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-Q190V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/29/2021
• Initial Date FDA Received: 07/20/2021
• Supplement Dates Manufacturer Received: 09/29/2021; 11/09/2021
• Supplement Dates FDA Received: 10/12/2021; 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-1292-2021
• Patient Sequence Number: 1
• Treatment: MAJ-2315, LOT H9422, GLIDESCOPE
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR
• Patient Sex: Female