MAUDE Adverse Event Report: AD-TECH MEDICAL INSTRUMENT CORP. CONNECTION SYSTEM; 12 CONTACT TECH-ATTACH CABLE

Catalog Number L-DCL-12BDIN

Device Problems Misconnection (1399); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/12/2014

Event Type  malfunction  

Event Description

A customer reported to ad-tech that two cables "were faulty, nearly all wires is shorted" surgery was delayed for half an hour and recording was delayed longer because of the cables.

Manufacturer Narrative

The customer feedback of the cable concern was provided to ad-tech on (b)(6)2014.During the investigation of the complaint, on (b)(6) 2014 ad-tech was made aware of a 30 minute delay in the surgical procedure.The delay in the surgical procedure due to the cable defect is the reported event that triggered the mdr.Ad-tech received the two impacted cables from the customer on (b)(6) 2014.A visual inspection and continuity analog/digital testing were performed that same day on the cables.Based on the results, the return evaluation does support the alleged deficiency reported in the complaint as it was found that the visual inspection failed on both cables due to the cables showing evidence of incorrect sterilization applied by the end-user and the continuity testing failed on both cables due to channels having cross connection.On (b)(4) 2014, it was confirmed that the customer did not sterilize the cables per ad-tech medical's directions for use (dfu).The customer confirmed that the cables were sterilized via autoclave at 134 degrees celsius.The customer application of autoclave sterilization is a probable cause of the cable failure.The customer has been reminded to apply recommended sterilization processes to the cables.

• Brand Name: CONNECTION SYSTEM
• Type of Device: 12 CONTACT TECH-ATTACH CABLE
• Manufacturer (Section D): AD-TECH MEDICAL INSTRUMENT CORP.; racine WI 53404
• Manufacturer Contact: 1901 william st.; racine, WI 53404 ; 2626341555
• MDR Report Key: 3966161
• MDR Text Key: 4632774
• Report Number: 2183456-2014-00004
• Device Sequence Number: 1
• Product Code: IKD
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2017
• Device Catalogue Number: L-DCL-12BDIN
• Device Lot Number: 310290
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/27/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• 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