MAUDE Adverse Event Report: COAPT LLC CONTROLSEAL ELECTRODE; CUTANEOUS EMG ELECTRODE

Device Problems Ambient Temperature Problem (2878); Temperature Problem (3022)

Patient Problems Superficial (First Degree) Burn (2685); Skin Inflammation/ Irritation (4545)

Event Date 04/25/2023

Event Type  Injury  

Event Description

Patient thermal burn on residual limb during prosthesis wear.After about 8 hours of continued use, patient doffed his prosthetic device and noticed thermal blisters on his residual limb.Upon further inspection, he found consistent hot spots with where other sensors were on the left side of his limb.He also noticed that the battery on that side seemed to have heated up or indented the socket.Patient did not feel any sensation of heat, and had his prosthetic in "freeze mode".Patient confirms he was not in direct heat while wearing the product, indicating that environmental heat exposure was not a likely cause.Patient returned the prosthetic arm system to his prosthetist (clinician) who subsequently send it to the prosthetic hand and battery manufacturer, psyonic (san diego, ca, https://www.Psyonic.Io/) for diagnosis and inspection.The investigation by the prosthetic hand and battery manufacturer, psyonic (san diego, ca, https://www.Psyonic.Io/) determined that a psyonic battery unit installed inside the prosthetic arm system became bent, which caused this battery damage; internal damage within the battery unit resulting in the battery cell overheating.Psyonic's investigation showed that the bending was likely caused by insufficient space within the device and the force of the patient's residual limb against the battery while donning the prosthetic.The excessive heat produced by the damaged battery would have been in close proximity to coapt's electrodes, and the heat would have been conducted from the extreme condition to the patients' skin through the metal of the electrodes, resulting in the minor burns incurred by the patient.

Manufacturer Narrative

Prosthetic manufacturer indicated that the heat generated by the bent battery was conducted through coapt dome electrodes.Coapt replaced the controller device out of an abundance of caution that the device was possible exposed to heat above operating temperature of 95°f, despite working as normal.Heat conduction is an inherent risk of metal electrodes, the cause of the heat was not due to coapt products.

• Brand Name: CONTROLSEAL ELECTRODE
• Type of Device: CUTANEOUS EMG ELECTRODE
• Manufacturer (Section D): COAPT LLC; 303 w institute place ste20; chicago IL 60610
• Manufacturer (Section G): COAPT LLC; 303 w institute pl ste200; chicago IL 60610
• Manufacturer Contact: blair lock ; 303 w institte pl ste200; chicago, IL 60610 ; 8442627800
• MDR Report Key: 17772547
• MDR Text Key: 323700707
• Report Number: 3010605876-2023-00001
• Device Sequence Number: 1
• Product Code: GXY
• UDI-Device Identifier: B618P1
• UDI-Public: +B618P1
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K223605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2023
• Initial Date FDA Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male