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

Model Number L-SRL-4DIN

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/02/2021

Event Type  malfunction  

Event Description

Customer informed us that the package label conflicted with the directions for use and asked us to clarify.There was no patient impact.

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 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
• Type of Device: 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
• MDR Text Key: 270816455
• Report Number: 2183456-2021-00008
• Device Sequence Number: 1
• Product Code: IKD
• UDI-Device Identifier: 00841823106216
• UDI-Public: (01)00841823106216(17)250501(10)0146512123050
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: L-SRL-4DIN
• Device Catalogue Number: L-SRL-4DIN
• Device Lot Number: 123050
• Date Manufacturer Received: 08/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2183456-08182021-C-001
• Patient Sequence Number: 1