MAUDE Adverse Event Report: AD-TECH MEDICAL INSTRUMENT CORP. DEPTH ELECTRODE

Catalog Number UNKNOWN

Device Problem Difficult to Remove (1528)

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

Event Date 09/14/2022

Event Type  malfunction  

Event Description

On september 15, 2022, a clinical specialist received a forwarded e-mail from a customer.It was stated that an electrode got hung up inside the anchor bolt when trying to be pulled out bedside.According to the customer, there was no impact to patient and there was no significant delay in surgery as a result of this issue.

Manufacturer Narrative

Our initial assessment of this issue was completed on 10/7/2022 and it was determined that no mdr was required.However, based on our preliminary risk assessment, it was determined that the severity of this issue would call for an mdr.This form was completed on 12/15/2022.While the customer reported no harm to the patient or delay in procedure there is the possibility of damage to healthy tissue.Out of an abundance of caution an mdr will be filed.This mdr was filed past the 30 day timeframe.

Event Description

On september 15, 2022, a clinical specialist received a forwarded e-mail from a customer.It was stated that an electrode got hung up inside the anchor bolt when trying to be pulled out bedside.According to the customer, there was no impact to patient and there was no significant delay in surgery as a result of this issue.

Manufacturer Narrative

Our initial assessment of this issue was completed on 10/7/2022 and it was determined that no mdr was required.However, based on our preliminary risk assessment, it was determined that the severity of this issue would call for an mdr.This form was completed on 12/15/2022.While the customer reported no harm to the patient or delay in procedure there is the possibility of damage to healthy tissue.Out of an abundance of caution an mdr will be filed.This mdr was filed past the 30 day timeframe.Updated 2-17-2023: the product was not returned for evaluation therefore no root cause could be identified.The damage to healthy tissue is being evaluated against the use fmea since the deficiency is a result of the use of the electrode and not a result of the process of testing the electrode.The risk assessment concluded that the calculated occurrence remains "acceptable" and no further action is needed at this time.

• Brand Name: DEPTH ELECTRODE
• Type of Device: DEPTH ELECTRODE
• 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: monique-elise alamina ; 400 west oakview parkway; oak creek, WI 53154 ; 2626341555
• MDR Report Key: 16098549
• MDR Text Key: 308565699
• Report Number: 2183456-2023-00001
• Device Sequence Number: 1
• Product Code: GZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163355
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/17/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2022
• Initial Date FDA Received: 01/04/2023
• Supplement Dates Manufacturer Received: 09/15/2022
• Supplement Dates FDA Received: 02/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1