MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ENERGY CART

Model Number	TC-E400
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.Based on the investigation results, the indicated phenomenon could have been caused by the following factors: the caster was easily broken because a load was applied to the caster, such as some impact during the transportation.The caster was broken due to the user¿s improper handling.As the results of the dhr review, it was confirmed that there was no abnormality in manufacturing, concession and variation this mdr is being submitted retrospectively as part of a remediation effort related to recent system and process changes.A capa has been opened to manage the actions related to remediation of this issue and any required mdr reporting.
Event or Problem Description
A user facility reported that a right back caster was broken on an energy cart.No patient involvement or injuries were reported.No additional information has been obtained.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information from the customer and the manufacturer date.Additional information from the customer states the event was found during transport from the hospital to the equipment warehouse.The customer reported that if the cart was inspected, no damage was found.The customer was manipulating the equipment to get it into the car to transport it to the warehouse.The customer hit himself and noticed the damage.The tc-e400 carriage mounting post part was broke.The rubber rim on the wheels were not broken or degraded.The wheels are approximately 2 years old.When the cart was not in use (without weight), it was dissembled.There was no repair report for this event as the customer rejected the repair quote.

• Brand Name: ENERGY CART
• Common Device Name: CART
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10977736
• Report Number: 8010047-2020-10117
• Device Sequence Number: 19008383
• Product Code: FEM
• UDI-Device Identifier: 04953170292132
• UDI-Public: 04953170292132
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: CLASS1-EXMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TC-E400
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 12/09/2020
• Supplement Report FDA Received Date: 02/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1