MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT 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  

Manufacturer Narrative

The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

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).This report is for patient identifier (b)(6).

• Brand Name: SINGLE USE DISTAL COVER
• Type of Device: ENDOSCOPE PATIENT PROTECTION CAP, SINGLE-USE
• 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: 16219589
• MDR Text Key: 307880915
• Report Number: 3003637092-2023-00013
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170403019
• UDI-Public: 04953170403019
• 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
• Type of Report: Initial,Followup
• Report Date: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ERCP SCOPE MODEL TJF-Q190V SERIAL NUMBER UNKNOWN
• Patient Outcome(s): Required Intervention