MAUDE Adverse Event Report: AD-TECH MEDICAL INSTRUMENT CORP. FREMAP ELECTRODE; SURGICAL NERVE STIMULATOR/LOCATOR

Model Number	DCNE-01-05X
Medical Device Problem Code	Device Contaminated at the User Facility (4064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During routine incoming inspection the distributor noted a foriegn material in the sterile product pouch.

• Brand Name: FREMAP ELECTRODE
• Common Device Name: SURGICAL NERVE STIMULATOR/LOCATOR
• 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: 14246033
• Report Number: 2183456-2022-00010
• Device Sequence Number: 12153346
• Product Code: ETN
• UDI-Device Identifier: 00841823108487
• UDI-Public: (01)00841823108487(17)231201(10)0152632789790791
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K152769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/28/2022

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
• Device Expiration Date: 12/01/2023
• Device Model Number: DCNE-01-05X
• Device Catalogue Number: DCNE-01-05X
• Device Lot Number: 789790791
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 04/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown