MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE DISTAL COVER; ENDOSCOPE PATIENT PROTECTION CAP, SINGLE-USE

Model Number MAJ-2315

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/28/2022

Event Type  Injury  

Event Description

The customer reported to olympus that during the procedure, the doctor withdrew the scope from the patient¿s esophagus and the distal cover had fallen off.Three attempts were made with three different scope in an attempt to retrieve the distal cover but were unsuccessful and the procedure was aborted.The patient coughed up the distal cover once he/she woke up from anesthesia and the distal cover was recovered.This complaint requires 2 reports.The related patient identifiers are as follows: (b)(6): maj-2315 (b)(6) : tjf-q190v this medwatch report is for patient identifier (b)(6).The mfr medwatch report associated with this event was submitted on time under manufacturer report # 3003637092 - 2023 - 00013.Upon review olympus is submitting the corresponding importer medwatch report.

• Brand Name: SINGLE USE DISTAL COVER
• Type of Device: ENDOSCOPE PATIENT PROTECTION CAP, SINGLE-USE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 17043764
• MDR Text Key: 316390880
• Report Number: 2429304-2023-00178
• Device Sequence Number: 1
• Product Code: NWB
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/29/2022,06/01/2023

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/29/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/29/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/01/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TJF-Q190V SERIAL NUMBER UNKNOWN.
• Patient Outcome(s): Required Intervention