MAUDE Adverse Event Report: AD-TECH MEDICAL INSTRUMENT CORP. CABRIO CABLE; ELECTRODE CABLE

Model Number	L-SRL-4DIN
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Customer informed us that the package label conflicted with the directions for use and asked us to clarify.There was no patient impact.
Additional Manufacturer Narrative
Updated 6/13/2022.As documented within the complaint, there was no impact to the patient as a result of this issue.Per our risk assessment, the risk remains alap (as low as possible) and matches that of the risk file.No updates are needed to the risk file at this time.This complaint coincides with correction 2183456-08182021-c-001 (recalls: z-2494-2021, z-2495-2021, z-2496-2021) and cause, corrections, corrective and preventative actions are detailed further in those reports.This complaint is closed and the trend code is being monitored for future occurence.
Event or Problem Description
Customer informed us that the package label conflicted with the directions for use and asked us to clarify.There was no patient impact.

• Brand Name: CABRIO CABLE
• Common Device Name: ELECTRODE CABLE
• Manufacturer (Section D): AD-TECH MEDICAL INSTRUMENT CORP.; 400 west oakview parkway; oak creek WI 53154
• Manufacturer (Section G): AD-TECH MEDICAL INSTRUMENT CORP.; 400 west oakview parkway; oak creek WI 53154
• Manufacturer Contact: pamela stogsdill ; 400 west oakview parkway; oak creek, WI 53154 ; 2626341555
• MDR Report Key: 12393838
• Report Number: 2183456-2021-00008
• Device Sequence Number: 16992256
• Product Code: IKD
• UDI-Device Identifier: 00841823106216
• UDI-Public: (01)00841823106216(17)250501(10)0146512123050
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2022

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 Expiration Date: 05/01/2025
• Device Model Number: L-SRL-4DIN
• Device Catalogue Number: L-SRL-4DIN
• Device Lot Number: 123050
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2021
• Supplement Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 08/31/2021
• Supplement Report FDA Received Date: 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2183456-08182021-C-001
• Patient Sequence Number: 1
• Patient Sex: Unknown