MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA III DUODENOVIDEOSCOPE

Model Number TJF-Q190V

Device Problem Crack (1135)

Patient Problem Unspecified Tissue Injury (4559)

Event Type  malfunction  

Event Description

Olympus received information that during an unknown procedure, the mucosa of stomach and esophagus was damaged by the slit of the disposable distal cover when the duodenovideoscope was removed from the patient.Due to the negative pressure applied by suction function, mucosa comes into the gap around the forceps elevator.This led to mucosal damage when the scope was removed.There were no reports of further patient or user harm associated with this event.This event will need two reports with patient identifiers: (b)(6) - duodenovideoscope, (b)(6) - distal cover.This report is for (b)(6).

Manufacturer Narrative

To date, this device has not been returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Correction to e and g2 for information inadvertently left out.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, it is likely the phenomenon occurred due to the following: the mucosa was sucked into the distal cover because the user operated suction while the distal end opening space was near the surface of mucosa.Since the user removed the subject device in this situation, the mucosa was damaged by the edge of the distal cover.The subject device was removed soon after the mucosa was sucked into the distal cover (while the mucosa was being sucked into the distal cover), which damaged the mucosa.The distal cover cracked at tear-off line by inappropriate attachment of the cover to the subject device.When the distal end was pressed against the surface of the mucosa in this situation, the mucosa was caught in the cracked cover and damaged.However, the root cause of the phenomenon could not be specified.The event can be prevented by following the instructions for use which state: "important information ¿ please read before use: examples of inappropriate handling 3.5 attaching accessories to the endoscope: attaching the single use distal cover" olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17278713
• MDR Text Key: 318769007
• Report Number: 9610595-2023-09831
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/22/2023
• Initial Date FDA Received: 07/07/2023
• Supplement Dates Manufacturer Received: 07/10/2023
• Supplement Dates FDA Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: MAJ-2315 UNKNOWN LOT.