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).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Three attempts were performed to obtain additional information, but no response was received from the customer.The device history record was unable to be reviewed for this device since the lot 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, and because the device was not returned, the phenomenon was not duplicated during device evaluation.Therefore, the root cause of the phenomenon could not be identified.Though the phenomenon was not confirmed during sampling inspection, possible causes for the dropout of maj-2315 are likely due to: chemicals such as anti-fogging agents adhered to the distal cover, and the rear end of the distal cover was damaged by chemical attack, making it easy to remove the cover from the endoscope, and /or the cover was easily removed from the scope due to insufficient attachment to the scope.Sampling inspection check was performed with results below: the parts supplier conducts sampling inspections of 3 parts for each production lot, and confirms that the parts conform to the specifications each time.Regarding the phenomenon, the instructions for use identify verbiage that could potentially prevent and detect the phenomenon: "please make sure that the distal cover is intact without any problem before installation, and it has no damage(crack) after installation.Also, do not use anti-fog agents as it is known that anti-fog agents will damage the cover." it was also noted there was a design change.We have verified that the distal cover does not come off from the distal end of the endoscope during procedure, and confirmed that the design change products satisfies the specifications.Based on the product code of the subject device of this report, the subject device is judged to be a product of the design change.Olympus will continue to monitor field performance for this device.

• 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