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

Model Number MAJ-2315

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/28/2021

Event Type  malfunction  

Event Description

An olympus sales representative reported that during an ercp the distal cover came off.It is unknown if the procedure was a diagnostic or therapeutic procedure.The distal cover was retrieved from the patient using a roth net.The procedure was completed and there was no patient injury reported.This report is related to a report with a patient identifier number (b)(6) for the duodenovideoscope.

Manufacturer Narrative

No device was returned to olympus for evaluation.The distal cover had undergone a design change in may 2022.Although the lot number of the subject device is unknown, since the date of occurrence was before the design change, the subject device is pre-counter measured device.Based on the legal manufacturer's investigation, it stated that if the distal cover is attached properly per ifu, the distal cover will not come off from the distal end of the endoscope.It was determined that the most likely cause of the distal cover detaching can be attributed to user handling.The root cause of the user¿s report cannot be conclusively determined, as the subject device was not returned to olympus, but the most likely causes for the reported phenomenon (distal end cover falling off) are as follows: (1) the distal end cover was inappropriately attached to the endoscope.(2) distal end cover has a crack and/ or pinhole.(3) chemical solutions such as anti-fog agent adhered to the distal end cover, which cause the distal end cover to break.4) during the procedure, the scope distal end received stress such as contact with mouthpiece, frictional load by being twisted/pushed/pulled in patient body.The device instruction manual includes the following caution and warning statements: ¿never use a single use distal cover with cracks or pinholes.Replace it with a new one.If a single use distal cover with cracks or pinholes is used, it could fall off during the examination and/or, it may cause thermal injury due to electric current leaks from cracks or pinholes when high-frequency cauterization treatment is performed.Also, using the single use distal cover with cracks may cause patient injury due to sharp edges." "inspection of accessories: inspection of the single use distal cover (maj-2315): should any irregularity be observed when inspecting the single use distal cover, do not use it.A single use distal cover with irregularity could not serve the endoscope properly and/or could fall off during the examination.Using the endoscope without the single use distal cover could cause patient injury and this could result in thermal injury when the endoscope is used with high-frequency endotherapy accessories.In addition, if the single use distal cover falls off in the oral cavity, it may cause aspiration or respiratory distress if not promptly identified and removed." attaching accessories to the endoscope: attaching the single use distal cover: ¿do not apply anti-fogging products, olive oil, or products containing petroleum-based substances (e.G., vaseline®) to the single use distal cover or the endoscope.These products may cause cracks in the single use distal cover.If a single use distal cover with cracks is used, it may cause patient injury such as: thermal injury from electric current leaks when performing high-frequency cauterization treatment./ damage or cuts to the mucosal membrane from sharp edges due to the cracks on the single use distal cover.- detach the single use distal cover from the distal end of the endoscope when the single use distal cover cannot be attached to the endoscope smoothly or any incorrect attaching procedure is noticed.If the single use distal cover is not attached properly, it may slip off or fall off the distal end during the examination.This could result in thermal injury when the endoscope is used with high-frequency endotherapy accessories.¿ based on the reproduction confirmation performed according to the pre-use inspection procedure in section 7.3 of the instruction manual using a sample device with lot number (h2311), it was confirmed that the reported was not duplicated.Quality evaluations of production prototypes have verified that the distal cover will not come off if it was attached correctly according to the instruction manual.The parts supplier conducts sampling inspection of three parts for each production lot and confirmed that the parts conform to the specifications.Based on the visual confirmation results, the reproduction confirmation results, investigation results of product specifications and the inspection results at the parts manufacturer, it is believed that the product conformed to the specifications.The device history record was unable to be reviewed, as the serial number of the device was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The manufacturing date cannot be identified as the lot number was not provided.This mdr is being submitted as part of a retrospective review and remediation effort based on enhancements made to the company¿s mdr and complaint handling processes.Capas have been opened to manage the actions that are being taken to remediate this issue and ensure any required mdr reporting is completed.

• 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 190-0 182; JA 190-0182
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17149489
• MDR Text Key: 318017281
• Report Number: 3003637092-2023-00136
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170403019
• UDI-Public: 04953170403019
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193182
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2023
• 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
• Date Manufacturer Received: 05/28/2021
• 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, SERIAL NUMBER UNKNOWN.