MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT SINGLE USE DISTAL COVER

Model Number MAJ-2315

Device Problem Use of Device Problem (1670)

Patient Problem Laceration(s) of Esophagus (2398)

Event Date 12/15/2022

Event Type  Injury  

Event Description

The customer reports during an unspecified procedure using an evis exera iii duodenovideoscope and a single use distal cover, the patient experienced a 15cm esophageal tear with no perforation.The physician aborted the case.Additional details regarding the patient and reproted event have been requested.At this time, no additional information has been provided.Case with patient identifier: (b)(6) reports the scope used in the procedure.Case with patient identifier: (b)(6) reports the single use distal cover used in the procedure.

Manufacturer Narrative

Correction and preventative action (capa) investigation has been opened to further investigate this issue.The device referenced in this report was not 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.This event has been reported by the importer on mdr#: 2429304-2023-00004.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been less than 1 year since the subject device was manufactured.Based on the results of the investigation, removing the endoscope while the end of the device is pressed against the mucous membrane by aspiration, may cause damage to the mucous membrane or collection of tissue fragments.This is applicable even if the distal cover after the design change was used, however, it was confirmed that the tissue invasiveness is less than that of the tip cover before the design change.Furthermore, per capa no.Omsc-hq-153-19, the mechanism of occurrence of this event has been found to be as follows: procedure is started without noticing cracks in the tip cover during pre-use inspection.By performing the suction operation with the tip in close contact with the mucous membrane, the mucous membrane enters between the tip cover and the elevator.The endoscope was removed with the mucous membrane inserted between the tip cover and the elevator (the tip was adsorbed on the mucous membrane).The mucous membrane that has entered at the cracked part of the tip cover is excised, and a piece of mucous membrane remains in the tip cover.Procedure is started without noticing cracks in the tip cover during pre-use inspection.Although no suction operation is performed, the mucous membrane enters between the tip cover and the elevator due to the strong contact between the tip and the mucous membrane.The endoscope is removed with the mucous membrane inserted between the tip cover and the elevator (the tip is in strong contact with the mucous membrane).The mucous membrane that has entered at the cracked part of the tip cover is excised, and a piece of mucous membrane remains in the tip cover.By performing the suction operation with the tip in close contact with the mucous membrane, the mucous membrane enters between the tip cover and the elevator.The endoscope was removed with the mucous membrane inserted between the tip cover and the elevator (the tip was adsorbed on the mucous membrane).The mucous membrane that has entered at the edge of the tip cover (around the u-shaped slit) is excised, and a piece of mucosa remains in the tip cover.The root cause has been identified as follows from the mechanism of occurrence: root cause 1: start the inspection without confirming that the tip cover is properly attached during the pre-use inspection (start the inspection with the tip cover cracked).Root cause 2: removing the endoscope with the tip adsorbed on the mucous membrane by suction operation.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿withdrawal of the endoscope: take caution applying suction when the distal end is in contact with the mucosal surface.The suction can cause the distal end to aspirate the mucosal membrane.Moving or withdrawing the endoscope under this condition may cause patient injury and/or bleeding.This can be more common while degassing in the stomach, suctioning debris, and operating in a narrow lumen (e.G., esophagus, duodenum).To prevent patient injury and bleeding, make sure to: only apply suction when the endoscope is stationary.After releasing the suction valve, check the endoscopic image to confirm that the mucosal membrane is not aspirated before moving the endoscope.Releasing the suction valve might not immediately release the mucosal membrane if it becomes aspirated.¿ this supplemental report includes information added to h4.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to correct d4 - unique identifier (udi) number to (b)(4).

• Brand Name: SINGLE USE DISTAL COVER
• Type of Device: DISTAL COVER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT; 34-3 hirai, hinode-machi; nishitama-gun, tokyo 190-0 182; JA 190-0182
• Manufacturer (Section G): OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT; 34-3 hirai, hinode-machi; nishitama-gun, tokyo
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16156372
• MDR Text Key: 307262651
• Report Number: 3003637092-2023-00009
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2023

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: MAJ-2315
• Device Lot Number: H2623
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/15/2022
• Initial Date FDA Received: 01/13/2023
• Supplement Dates Manufacturer Received: 02/06/2023; 11/29/2023
• Supplement Dates FDA Received: 02/16/2023; 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1292-2021
• Patient Sequence Number: 1
• Treatment: TJF-Q190V.
• Patient Outcome(s): Other