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

Model Number MAJ-2315

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/01/2022

Event Type  Injury  

Event Description

The customer reported in two different procedures, the distal cover fell off of the endoscope.The first patient event involved the olympus endoscope with distal cover was inserted without issues and it was noticed the clear cap started dislodging.It seemed to correct itself as it could not be seen anymore.After completing the procedure, upon withdrawal of the endoscope from the stomach, the distal cover was identified sitting in the patient's stomach.The physician had difficulty retrieving the distal cover while grasping with forceps and pulling it back up the esophagus.Eventually a thin part of the cap ripped and it had to be pushed back into the stomach.The physician needed to use a roth net and had some difficulty removing the distal cover.This patient was noted to have a narrow esophagus however the physician noted this should have not occurred.The second patient event happened approximately 1-2 months ago on an unknown date.While the physician was inserting the endoscope, the distal cover fell off and lodged in the posterior oropharynx.It is unknown how the distal cover was retrieved.The olympus area manager performed an in-service to all end users of the olympus endoscope and distal cover.After the in-service, there have not been any related incidents with the distal cover falling off of the endoscope.(b)(6), maj-2315 is for patient 1 with the distal cover falling off in the stomach requiring additional intervention to remove it.(b)(6), maj-2315 is for patient 2 with the distal cover lodging in the posterior oropharynx.This report is 1 of 2 for (b)(6), maj-2315 tjf-q190v is for patient 1 with the distal cover falling off in the stomach requiring additional intervention to remove it.

• Brand Name: SINGLE USE DISTAL COVER
• Type of Device: DISTAL COVER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 13952021
• MDR Text Key: 288273807
• Report Number: 2951238-2022-00363
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170403019
• UDI-Public: 04953170403019
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/01/2022,03/30/2022

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: MAJ-2315
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/01/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/01/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/30/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TJF-Q190V
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Female