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

Model Number MAJ-2315

Device Problem Crack (1135)

Patient Problem Unspecified Tissue Injury (4559)

Event Type  malfunction  

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.

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

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: since the suction operation was performed while the tip of the endoscope was in contact with the mucous membrane, the mucous membrane was caught in the gap between the scope's forceps elevator and the forceps channel, and between the forceps elevator and the distal cover.It is thought that the mucous membrane was damaged by pushing and pulling the endoscope in that state.It is also possible that the mucous membrane was damaged by removing the scope immediately after stopping the suction operation.Replication test has been conducted using a test scope with a distal cover attached and pig organ.Removal of the test scope from the pig organ was experimented under two parameters "distal cover with/without slight crack" and "suction activated/not activated to remove the scope".The test result shows that tissue is embedded in the distal cover after the scope is removed with suction activated, which is observed regardless of "distal cover with/without slight crack".More tissue is embedded when small crack is present on the distal cover and suction is activated during removal.This could cause more severe damage to tissue.When there is no crack on the distal cover and suction is not activated, no tissue is embedded in the distal cover.From the results of reproduction confirmation, it is confirmed that mucous membrane damage occurs when the suction operation is performed or when the removal operation is performed immediately after the suction operation.In addition, the root cause has been identified as follows from the mechanism of occurrence.When the following user's operations are applied to this device having the structure shown below, one of the patterns of the mechanism of occurrence occurs, and the tissue damage level of the mucous membrane increases, leading to harm.-compared to conventional products, there is a space for mucous membrane to enter between the elevator and the tip cover.-compared to conventional products, the tip cover has an edge (around the u-shaped slit), and the edge is in a position where it can easily come into contact with the mucous membrane.-root cause 1: started 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 handling precautions for this factor are described in the instruction manual as follows: ¿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.¿ olympus will continue to monitor field performance for this device.

• 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: 17278644
• MDR Text Key: 318588169
• Report Number: 3003637092-2023-00149
• 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: 08/09/2023

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: MAJ-2315
• Device Lot Number: UNKNOWN
• 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: 08/03/2023
• Supplement Dates FDA Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TJF-Q190V UNKNOWN SERIAL NUMBER