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

Model Number TJF-Q190V

Device Problem Use of Device Problem (1670)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946)

Event Date 07/13/2021

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It was reported by the customer, during an endoscopic retrograde cholangiopancreatography (ercp) using an evis exera iii duodenovideoscope (this report) and a maj-2315 disposable distal cover (reported in case with patient identifier (b)(6), difficulties were encountered in crossing the pylorus.The user noticed a hemorrhagic wound in the antrum, and the duodenoscope was removed from the patient.The distal cover had opened slightly in the middle and was said to have caused the reported the hemorrhagic wound.The user replaced the disposable distal cover with a second distal cover to complete the procedure.The reported issue led to the procedure time being 20 minutes longer than planned.The user stopped bleeding with three hemostatic clips and no further interventions were required.No additional consequences to the patient were reported.The user discarded the disposable cap.

Manufacturer Narrative

This report is being updated to provide investigation findings.New information is reported in d8, h6, and h10.The device history record (dhr) for the complaint device has been reviewed and it is confirmed that the device met all design and quality specification when it was shipped.The instructions for use (ifu) shipped with the device provides the user the following information related to the reported event: 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.Conclusion: the definitive cause of the reported events could not be established.Based on investigation findings, the following are presumed to be the likely causes: 1) user operates suction while distal end opening space was near the surface of mucosa, which causes the mucosa sucked into distal cover.When user tried to remove scope in this situation, the mucosa is damaged by the edge of the distal cover.2) distal cover cracks at tear-off line due to inappropriate attachment of distal cover to scope.When pressing distal end to surface of mucosa in this situation, the mucosa gets caught in the cracked cover and damaged, even though suction is not operated.Since the user noted that the cover had slightly torn in the center when withdrawing the device immediately after the suggested event was detected, we presume that the event more likely occurred due to number 2.Corrected data: the aware date for the reported event was 19jul2021 and the date of the report was 28sep2021 for mfr report number 8010047 - 2021 - 12394.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.

• 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: 12541103
• MDR Text Key: 273610812
• Report Number: 8010047-2021-12394
• 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,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1292-2021
• Patient Sequence Number: 1
• Treatment: MAJ-2315.; MAJ-2315
• Patient Outcome(s): Other; Required Intervention