MAUDE Adverse Event Report: AMICO CLINICAL SOLUTIONS CORP ICE30M; SURGICAL LIGHT

Model Number ICE30M

Device Problem Misassembly During Maintenance/Repair (4054)

Patient Problem Bruise/Contusion (1754)

Event Date 07/28/2020

Event Type  malfunction  

Manufacturer Narrative

From our investigation, it appears that the surgical light was serviced in april 2020.There is a pm sticker attached to the cover of the surgical light indicating next service due april 2021.There was no damage to the threads in the spring arm so the screw did not fall out on its own.We also have photos at the time of installation indicating that the assembly of the light to the spring arm was done correctly.The instructions in the owner's manual also indicate a warning to ensure that the cotter key is inserted and secured correctly to prevent separation.We have already sent a replacement light and our technician also inspected other lights in the hospital to ensure that the cotter key and the screw holding the assembly are installed.In addition to visual inspection, the light was reinstalled at the factory along with the mating spring arm.The entire system was then tested and it performed as intended without any failures.The testing was conducted over a period of 2 weeks to help recreate the failure without success.If the cotter key remains installed correctly there is no possibility of failure.

Event Description

On (b)(6) 2020, during a surgical procedure at (b)(6) hospital, a ice30m surgical light (s/n (b)(4)) separated from the spring arm as a radiology technician was positioning the light.The light began to fall and the technician assisted in redirecting the light away from the top of the patient.The light hit the table and patients posterior side causing bruising to the lower buttock.An amico technician was immediately sent onsite to investigate and discovered that there was a missing screw in the cotter key cover.The screw was securely installed at the time of installation.The missing screw is believed to be due to maintenance work conducted in april 2020 (based on the next pm sticker with date of 2021).It is believed that due to the lack of the screw over time the cotter key cover rotated and potentially allowed the cotter key to dislodge.This resulted in the separation of the light from the spring arm.There was also no damage to the threaded hole in the spring arm and a new screw was able to be re-installed during the inspection.

• Brand Name: ICE30M
• Type of Device: SURGICAL LIGHT
• Manufacturer (Section D): AMICO CLINICAL SOLUTIONS CORP; 122b east beaver creek rd.; richmond hill, on L4B 1 G6; CA L4B 1G6
• Manufacturer (Section G): AMICO CLINICAL SOLUTIONS CORP.; 122b east beaver creek rd.; richmond hill, on L4B 1 G6; CA L4B 1G6
• Manufacturer Contact: agustin garcia de paredes ; 122b east beaver creek rd.; richmond hill, on L4B 1-G6 ; CA L4B 1G6
• MDR Report Key: 10476921
• MDR Text Key: 242661856
• Report Number: 1000214453-2020-00001
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ICE30M
• Device Catalogue Number: ICE30M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Date Manufacturer Received: 08/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention