MAUDE Adverse Event Report: KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. TC-C3 TROLLEY US SET 3; TC SERIES OF ENDOSCOPY WORKSTATIONS

Model Number K10030136

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The user returned a tc-c3 trolley serial number (b)(4) for the evaluation of the tc-c3 cart freezes when wheeling around.The user complaint was not confirmed.Olympus performed a visual inspection on the device and noted that the device has one damaged and missing castor.The missing castor was not returned for evaluation.The three other castors on the device appear to have normal wear and tear.We attempted to apply the brakes for each castor, and verified that each brake was working properly.The tc-c3 trolley moved freely without extra force but as the device is missing one castor it is difficult to balance the trolley.As per instruction for use (ifu), ¿the compact trolley has 4 braked castors.Ensure all brakes are applied prior to use and released before moving the compact trolley.¿ the ifu states that for safety the castors should be inspected every six months.Please see warnings and notes from ifu below.Do not exceed the load capacity of the trolley as specified in chapter 7.To minimize risk of injury, it is recommended that heavy items are placed on the mobile compact trolley by two people working together.Ensure electrical items used on the mobile compact trolley are positioned centrally on the shelves.Avoid contact of the castor wheels with oil and avoid a buildup of floor cleaning wax and polish as these will impair the antistatic effectiveness of the castors.We are unable to investigate the root cause as the castor is not being returned to the original equipment manufacturer and the data available is not sufficient to determine a root cause, however it is important that the maintenance identified in the wm-np2 workstation instruction is followed on the castors.

Event Description

The user facility reported that one of the castors on the tc-c3 cart freezes when wheeling around, and the cart then requires force to move the cart.There was no patient involvement.No additional information was provided.

• Brand Name: TC-C3 TROLLEY US SET 3
• Type of Device: TC SERIES OF ENDOSCOPY WORKSTATIONS
• Manufacturer (Section D): KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.; keymed house, stock road; southend-on-sea, essex SS2 5 QH; UK SS2 5QH
• Manufacturer Contact: alison prior ; keymed house, stock road; southend on sea, essex SS25Q-H ; UK SS25QH ; 0441702616
• MDR Report Key: 10708120
• MDR Text Key: 213696381
• Report Number: 9611174-2020-00036
• Device Sequence Number: 1
• Product Code: FEM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: K10030136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1